Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
- Conditions
- Arthritis, Psoriatic
- Interventions
- Registration Number
- NCT01976364
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.
This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 686
- Previous participation in qualifying PsA study involving tofacitinib
- Time from End of Study visit of qualifying study is >3 months.
- Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.
Sub-study Inclusion Criteria:
- Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study
- Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)
Sub-study Exclusion Criteria:
-Subjects who are receiving methotrexate by a route other than oral
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tofacitinib Placebo Methotrexate - Tofacitinib Tofacitinib - Tofacitinib Methotrexate -
- Primary Outcome Measures
Name Time Method Number of Adverse Events (AEs) by Severity Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Number of Participants With Abnormal Clinical Laboratory Values Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin \[total, direct, indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 Sub-study: Baseline (Day 1), Month 6 HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 Sub-study: Baseline (Day 1), Month 6 PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study) Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin\[total,direct,indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.
- Secondary Outcome Measures
Name Time Method Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status.
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 PsARC is comprised of 4 clinical improvement criteria: greater than or equal to (\>=) 20% improvement in PhyGA (VAS), \>=20% improvement in PtGA; and \>= 30% reduction in the number of tender joints; and \>=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this outcome measure.
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represents better vitality.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity.
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 PASI: combined assessment of lesion severity and body area affected into single score; range =0 (no disease) -72 (maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0 (0%) - 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1 =slight, 2 =moderate, 3 =marked, 4 =very marked. Final PASI =sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis severity score for a participant was 0-60. Higher score indicated greater severity.
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness was recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this outcome measure.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting \& carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence \& extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless \["washed out"\],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; \& d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless \["washed out"\],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12 PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in mm, swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), SF-36 physical component summary (norm-based domain score were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and CRP in mg/L. PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12 Sub-study: Months 1, 3, 6, 9 and 12 A psoriatic arthritis participant was considered with minimal disease activity if participant had \>= 5 of 7 criteria: 1) tender/painful joint count less than or equals to (\<=) 1; (2) swollen joint count \<=1; (3) BSA \<=3%; (4) Patient Assessment of Arthritis Pain (VAS) \<=15 mm; (5) PtGA (VAS) \<=20 mm; (6) HAQ-DI score \<=0.5; (7) tender entheseal points (using LEI) \<=1.
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 Joints were assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Sixty-six (66) joints were assessed for swelling. The 66 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12 Months 1, 3, 6, 9 and 12 PsARC was comprised of 4 clinical improvement criteria: \>=20% improvement in PhyGA (VAS), \>=20% improvement in PtGA; and \>= 30% reduction in the number of tender joints; and \>=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage (Head and neck = 10 handprints \[1 handprint =10%\], upper extremities = 20 handprints \[1 handprint =5%\], Trunk (including axillae and groin) = 30 handprints \[1 handprint =3.33%\], lower extremities (including buttocks) = 40 handprints \[1 handprint =2.5%\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 68 joints were assessed to determine joints that are considered tender or painful. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints). The 68 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 Participants assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. Higher score indicated more severe pain.
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless \["washed out"\],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12 HAQ-DI assessed the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Sub-study: Months 1, 3, 6, 9 and 12 Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and independent of the PtGA and Patient Assessment of Arthritis Pain. The investigator's response was recorded using a 100 mm VAS where 0 =PSA not active at all and 100 =PSA extremely active. Higher score indicated more PSA.
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; \& d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represented better vitality.
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36 Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36 FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless \["washed out"\],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12 Baseline (Day 1), Months 1, 3, 6, 9 and 12 The PGA-PsO is a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12 Sub-study: Months 1, 3, 6, 9 and 12 Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12 Sub-study: Months 1, 3, 6, 9 and 12 Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participant's response were recorded using a 0 - 100 mm VAS where 0 =not affected at all and 100 =extremely affected. Higher score indicated worse condition due to PSA.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this measure.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless \["washed out"\],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless \["washed out"\],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard verticle 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12 Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12 EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this measure.
Trial Locations
- Locations (151)
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
ZNA Jan Palfijn
🇧🇪Merksem, Belgium
Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
🇧🇷Porto Alegre, RS, Brazil
Multiprofile hospital for active treatment Kaspela EOOD
🇧🇬Plovdiv, Bulgaria
Revmatologie s.r.o.
🇨🇿Brno, Czechia
Vesalion s.r.o.
🇨🇿Ostrava, Czechia
Medizinische Universitaetsklinik Freiburg
🇩🇪Freiburg, Germany
Elisabeth Klinik Bigge
🇩🇪Olsberg, Germany
Revita Reumatologiai Rendelo
🇭🇺Budapest, Hungary
Csolnoky Ferenc Korhaz
🇭🇺Veszprem, Hungary
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Guillermo Valenzuela, MD PA dba Integral Rheumatology & Immunology Specialists
🇺🇸Plantation, Florida, United States
St. Luke's Clinic - Rheumatology
🇺🇸Boise, Idaho, United States
St. Luke's Intermountain Research Center
🇺🇸Boise, Idaho, United States
Klein and Associates, M.D., P.A.
🇺🇸Hagerstown, Maryland, United States
University Hospitals of Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
St. Vincent's Hospital (Melbourne)
🇦🇺Fitzroy, Victoria, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
St. Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Seattle Rheumatology Associates
🇺🇸Seattle, Washington, United States
REUMEX, s.r.o
🇸🇰Rimavska Sobota, Slovakia
Hospital Clinico de Santiago
🇪🇸Santiago de Compostela, A Coruna, Spain
San Diego Arthritis Medical Clinic
🇺🇸San Diego, California, United States
Cincinnati Rheumatic Disease Study Group, Inc.
🇺🇸Cincinnati, Ohio, United States
Reumaclinic
🇧🇪Genk, Belgium
Hospital General de Culiacan Dr. Bernardo J. Gastelum
🇲🇽Culiacan, Sinaloa, Mexico
Sanatorio CEMSI Chapultepec
🇲🇽Culiacan, Sinaloa, Mexico
Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
🇬🇧Goodmayes, Essex, United Kingdom
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
🇲🇽Culiacan, Sinaloa, Mexico
Hopital Erasme - Clinique Universitaire de Bruxelles
🇧🇪Brussels, Belgium
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Hospital Angeles Clinica Londres
🇲🇽Mexico City, D.F, Mexico
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
🇵🇱Elblag, Poland
Magyar Honvedseg Egeszsegugyi Kozpont, Reumatologiai Osztaly
🇭🇺Budapest, Hungary
New England Research Associates, LLC
🇺🇸Bridgeport, Connecticut, United States
University Hospital Leuven
🇧🇪Leuven, Belgium
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
🇺🇸Summerville, South Carolina, United States
UMHAT "Dr. G. Stranski" EAD, Department of Rheumatology
🇧🇬Pleven, Bulgaria
Centrum Medyczne Pratia S.A. Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik
🇵🇱Bialystok, Poland
Top-Medical Sp. z o. o.
🇵🇱Lublin, Poland
Rheuma-Medicus Zaklad Opieki Zdrowotnej
🇵🇱Warszawa, Poland
State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a.N.V. Solovyev
🇷🇺Yaroslavl, Russian Federation
Chang Gung Medical Foundation-Kaohsiung Branch
🇨🇳Kaohsiung City, Taiwan
Arizona Arthritis & Rheumatology Associates, P.C.
🇺🇸Glendale, Arizona, United States
Arthritis Clinic
🇺🇸Jackson, Tennessee, United States
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Multiprofile Hospital for Active Treatment - Plovdiv AD
🇧🇬Plovdiv, Bulgaria
Medical Center - "New rehabilitation center" EOOD
🇧🇬Stara Zagora, Bulgaria
Grupo Medico Camino S.C.
🇲🇽Mexico City, Distrito Federal, Mexico
Unidad Reumatologica Las Americas S.C.P.
🇲🇽Merida, Yucatan, Mexico
State Autonomous Healthcare lnstitution of Yaroslavl Region "Clinical Hospital of Emergency Medical
🇷🇺Yaroslavl, Russian Federation
Nestatna reumatologicka ambulancia
🇸🇰Bratislava, Slovakia
SBIH of Moscow "City Clinical Hospital #1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
🇷🇺Moscow, Russian Federation
Cliditer, S.A. DE C.V.
🇲🇽Mexico City, Distrito Federal, Mexico
Christus Muguerza del Parque S.A. de C.V.
🇲🇽Chihuahua, Mexico
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.
🇵🇱Bialystok, Poland
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
🇵🇱Lublin, Poland
State Autonomic Healthcare Institution ''City Clinical Hospital # 7''
🇷🇺Kazan, Republic OF Tatarstan, Russian Federation
Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
🇵🇱Grodzisk Mazowiecki, Poland
Regional State Budgetary Health Care Institution of Karelia Republic
🇷🇺Petrozavodsk, Russian Federation
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
🇷🇺Novosibirsk, Russian Federation
State Institution of Healthcare Regional Clinical Hospital
🇷🇺Saratov, Russian Federation
State Budget Educational Institution of Highest Professional Education
🇷🇺Tomsk, Russian Federation
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
MEDMAN s.r.o. - reumatologicka ambulancia
🇸🇰Martin, Slovakia
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Rheumatology Associates, PC
🇺🇸Birmingham, Alabama, United States
Rheumatology Associates of North Alabama, PC
🇺🇸Huntsville, Alabama, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Stanford Anatomic Pathology and Clinical Lab
🇺🇸Stanford, California, United States
Stanford Health Care Department of Pharmacy lnvestigational Drug Services
🇺🇸Stanford, California, United States
Stanford University Hospitals and Clinics
🇺🇸Stanford, California, United States
Arthritis Center, Inc.
🇺🇸Palm Harbour, Florida, United States
Rheumatology Associates of Central Florida, PA
🇺🇸Orlando, Florida, United States
Millennium Research
🇺🇸Ormond Beach, Florida, United States
Florida Medical Clinic, P.A.
🇺🇸Zephyrhills, Florida, United States
Bluegrass Community Research, Inc.
🇺🇸Lexington, Kentucky, United States
St. Paul Rheumatology, P.A.
🇺🇸Eagan, Minnesota, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Clayton Medical Research
🇺🇸Saint Louis, Missouri, United States
Paramount Medical Research & Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
East Penn Rheumatology Associates, PC
🇺🇸Bethlehem, Pennsylvania, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Adriana Pop-Moody MD Clinic PA
🇺🇸Corpus Christi, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Cypress, Texas, United States
Investigational Drug Services
🇺🇸Salt Lake City, Utah, United States
University of Utah Hospital & Clinics
🇺🇸Salt Lake City, Utah, United States
University of Utah Hospitals and Clinics - Clinie 2
🇺🇸Salt Lake City, Utah, United States
Pacific Private Clinic
🇦🇺Southport, Queensland, Australia
Rheumatology Research Unit
🇦🇺Maroochydore, Queensland, Australia
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
EDUMED - Educação em Saùde SS Ltda
🇧🇷Curitiba, PR, Brazil
CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
🇧🇷Juiz de Fora, MG, Brazil
Stavovska, s.r.o.
🇨🇿Brno, Czechia
K. Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Revmacentrum MUDr. Mostera, s.r.o.
🇨🇿Brno, Czechia
X-Medica, s.r.o.
🇨🇿Brno, Czechia
Revmatologicky ustav - Lekarna
🇨🇿Praha 2, Czechia
Rheumapraxis Steglitz
🇩🇪Berlin, Germany
Revmatologicky ustav
🇨🇿Praha 2, Czechia
Revmatologicka ambulance
🇨🇿Praha 4, Czechia
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
MEDICAL PLUS, s.r.o.
🇨🇿Uherske Hradiste, Czechia
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Rheumazentrum Prof. Dr. med Gunther Neeck
🇩🇪Bad Doberan, Mecklenburg-vorp, Germany
CIRI, Centrum fuer innovative Diagnostik und Therapie Rheumatologie und Immunologie (GmbH)
🇩🇪Frankfurt am Main, Germany
University Hospital of Cologne
🇩🇪Koeln, Germany
Schlosspark-Klinik
🇩🇪Berlin, Germany
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
🇩🇪Homburg, Germany
Diagnoscan Magyarország Kft.
🇭🇺Budapest, Hungary
Budapest Fovaros II. keruleti Onkormanyzat Egeszsegugyi Szolgalata- Rontgen- Ultrahang
🇭🇺Budapest, Hungary
Qualiclinic Kft.
🇭🇺Budapest, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont - Kozponti Radiologiai Diagnosztika Osztaly
🇭🇺Budapest, Hungary
Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
🇭🇺Veszprem, Hungary
Centro Integral en Reumatologia S.A. de C.V.
🇲🇽Guadalajara, Jalisco, Mexico
Instituto Medico Panamericano, S.A de C.V.
🇲🇽Merida, Yucatan, Mexico
Investigacion y Biomedicina de Chihuahua SC
🇲🇽Chihuahua, Mexico
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion Clinica En
🇲🇽Merida, Yucatan, Mexico
ClinicMed Daniluk, Nowak Spolka Jawna
🇵🇱Bialystok, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
🇵🇱Elblag, Poland
Centrum Radiologii
🇵🇱Elblag, Poland
Wojewodzki Szpital Zespolony, Zaklad Radiologii
🇵🇱Elblag, Poland
Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
🇵🇱Lodz, Poland
NZOZ Lecznica MAK-MED s.c.
🇵🇱Nadarzyn, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
🇵🇱Poznan, Poland
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
🇵🇱Torun, Poland
Reumatika Centrum Reumatologii NZOZ
🇵🇱Warszawa, Poland
Synexus Polska Oddzial we Wroclawiu
🇵🇱Wroclaw, Poland
Research Institution of Fundamental and Clinical Immunology
🇷🇺Novosibirsk, Russian Federation
Complexo Hospitalario Universitario A Coruna
🇪🇸A Coruna, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
Hospital Quiron Salud Infanta Luisa
🇪🇸Sevilla, Spain
Buddhist Dalin Tzu Chi General Hospital
🇨🇳Chia-Yi, Taiwan
The Dudley Group NHS Foundation Trust
🇬🇧Dudley, WEST Midlands, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, WEST Yorkshire, United Kingdom
Bradford Royal lnfirmary, BTHFT
🇬🇧Bradford, WEST Yorkshire, United Kingdom
Royal United Hospitals NHS Foundation Trust
🇬🇧Bath, United Kingdom
York Teaching Hospital NHS Foundation Trust
🇬🇧York, United Kingdom
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Wirral University Teaching Hospital NHS Foundation Trust
🇬🇧Upton, Wirral, United Kingdom
Barking Havering and Redbridge University Hospitals NHS Trust
🇬🇧Romford, Essex, United Kingdom