Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

Completed

Conditions: Psoriatic Arthritis

Registration Number: NCT04517669

Lead Sponsor: Pfizer

Brief Summary: This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 116

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

Patients aged ≥ 18 years
Moderate to severe PsA disease activity diagnosed
Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
Patients are treatment naïve to tofacitinib on the date of providing informed consent
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Patients on DMARDs must have not had a treatment change in the past 3 months

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
Receipt of any investigational drug within 3 months before study inclusion
Patient is pregnant or breastfeeding
Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
Active treatment for a malignancy
Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6	At Month 6	PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12	At Month 3 and Month 12	PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	A participant was classified as MDA achieved if they met 5 of 7 criteria: (i) (TJC66) \<=1, (ii) (SJC68)\<=1, (iii) psoriasis area and severity index (PASI) score \<=1 (PASI=combined assessment of lesion severity and area affected into single score; range=0 \[no disease\] to 72 \[maximal disease\], higher scores=more disease. or body surface area (BSA) \<=3%,(iv) patient pain assessment (VAS, 0-100) \<=15; where 0='no pain' and 100='pain as severe as can be imagined', higher scores=more pain, (v) patient global assessment (VAS, 0-100) \<=20, where 0='lowest level of disease activity' and 100= 'highest level of disease activity, higher scores=more disease activity, (vi) health assessment questionnaire-disability index (HAQ- DI) \<=0.5; scale ranged=0-3, where 0='normal or no difficulty' and 3='inability to perform', higher scores=more difficulty, (vii) tender enthesial points \<=1 using Leed's index range=0=non tender to 6=more enthesitis burden, higher scores=more burden.
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. Remission was defined as PASDAS score less than or equal to (\<=) 1.9.
Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	DAPSA was composite disease activity measure and was calculated as: SJC66 + TJC68 + patient global assessment VAS (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity) + patient pain assessment (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain) + CRP (mg/dL). DAPSA score ranged from 0 to 164, higher scores indicated more disease activity. Remission was defined as DAPSA score =\<4.0.
Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12	Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12	PsAID12: questionnaire used for evaluating how much PsA impacted quality of life (QoL) and comprised of following domains: Pain, Fatigue, Skin problems, Work and/or leisure activities, Function, Discomfort, Sleep disturbance, Coping, Anxiety, Embarrassment, Social life and Depression. Each one of domain was based on a 0-10 numerical rating scale (NRS) and with different weight. PsAID12= (PsAID12.Q1 \[pain\] NRS value\3) +(PsAID12.Q2\[fatigue\] NRS value\2) +(PsAID12.Q3 \[skin\] NRS value\2) +(PsAID12.Q4\[Work and/or leisure activities\] NRS value\2) +(PsAID12.Q5\[function\] NRS value\2) +(PsAID12.Q6\[discomfort\]NRS value\2) +(PsAID12.Q7\[sleep\] NRS value\2) +(PsAID12.Q8 \[coping\]NRS value\1) +(PsAID12.Q9\[anxiety\] NRS value\1) +(PsAID12.Q10\[embarrassment\] NRS value\1) +(PsAID12.Q11\[social life\] NRS value\1) +(PsAID12.Q12\[depression\] NRS value\1). Total is divided by 20 for final score. Range of final PsAID score is 0-10 (higher numbers indicate worse status).
Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12	Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12	The SPARCC-EI evaluated 16 enthesial sites: greater trochanter (Right/Left \[R/L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles (R/L), lateral epicondyles (R/L) and supraspinatus insertion (R/L) for the presence or absence of tenderness. Tenderness at each site was quantified as: 0 = non-tender and 1 = tender. The maximum score of the SPARCC-EI was 16. SPARCC-EI score range: 0 (no enthesitis) to 16 (enthesitis is present at all assessed sites), higher scores indicated more presence of enthesitis.
Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	BMI = Weight (kilograms \[kg\]) / Height (meter square \[m\]\^2). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. In this outcome measure, participants with PASDAS scores are reported according to BMI categories of 18.5 - \<25 kg/m\^2, 25 - \<30 kg/m\^2, \>= 30 kg/m\^2 and missing.
Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Participants who achieved LDA according to treatment line were reported in this outcome measure. Treatment line included: tofacitinib monotherapy, combination therapy with MTX, and combination therapy with other csDMARDs. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Duration of current episode of symptoms prior to enrollment were presented as: \< 6, \>=6 weeks. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	ESR result=abnormal if test result was above normal range. ESR normal range:0-50 years(male \<15 mm/h, female \<20 mm/h), 51-85 years(\<20 mm/h males and \<30 mm/h females),older than 85 years(\<30 mm/h males and \<42 mm/h females). Number of participants who achieved LDA according to ESR results(normal and abnormal) were reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following:participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score=0-6;0=non tender,6=more enthesitis burden; tender dactylitis digit score=0-3,0=no tenderness,3=participant withdrew digit; PCS of SF-36 score=0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged=0(no disease)to 10(severe disease);higher scores=more severe disease.
Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	For CRP, result was considered abnormal if t the test result was above the normal range (0.3 to 10 mg/L). LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Number of participants who achieved LDA according to presence (present/absent) of rheumatoid nodules is presented in this outcome measure. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Unequivocal radiological erosion: 'present',if Sharp-Van der Heijde modified score (S-VH MS)for erosion \>0;'absent',if S-VH MS for erosion score=0. S-VH MS sum of erosion,JSN scores(range 0-528). Higher score=more severe disease. If a component score is missing, S-VH MS is missing. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA,100=maximum DA; TJC(0-68); SJC(0-66); LEI score range=0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score range=0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0(no disease)to 10(severe disease); higher scores=more severe disease.
Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Unequivocal Bony decalcification was reported as present or absent at enrollment. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Arthritis at enrollment was identified when a participant reported swelling and/or tenderness/pain in any joint. Number of participants who achieved LDA according to presence (Yes/No) of symmetric arthritis was reported. LDA was defined as PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Hand joints included metacarpal phalangeal joints(MCP), finger proximal interphalangeal and finger distal interphalangeal joints. Number of participants who achieved LDA according to presence(Yes/No) of arthritis of any of hand joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA, each scored on 100 mm VAS,0=no DA,100=maximum DA;TJC(0-68); SJC(0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal, finger distal interphalangeal and tarsus/midfoot(feet) joints. Large joints=glenohumeral, elbows, hips, knees and ankles joint. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of only 1 medium-large joint was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68);SJC(0-66); LEI score ranging from 0-6;0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3;0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100;0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal (IP), finger distal interphalangeal, tarsus/midfoot (feet). Large joints=glenohumeral, elbows, hips, knees, ankles. Small joints=MCP, proximal IP, second through fifth metatarsal phalangeal (MTP), thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) arthritis of 2-10 medium-large joints and/or 1-3 small joints was reported. LDA=PASDAS score =\<3.2. PASDAS is a composite PsA activity score including: participant /physician global (VAS 0-100; 0=no DA, 100=maximum DA), TJC (0-68), SJC (0-66), LEI (0-6; 0=non tender, 6=more enthesitis burden), tender dactylitis digit score (0-3; 0=no tenderness, 3=participant withdrew digit), SF-36 PCS (0-100; 0=severe physical health limitations, 100=excellent physical health),CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Large joints=glenohumeral, elbows, hips, knees and ankles joint. Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of 4-10 small joints with or without involvement of large joints was reported. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68); SJC(0-66); LEI score range=0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12	At Month 3, Month 6 and Month 12	Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of \>10 joints (with at least one small joint) was reported in this outcome measure. LDA=PASDAS score =\<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score ranging from 0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12	Baseline (measurement at enrollment), Month 3, Month 6 and Month 12	The SF-36 is a participant administered scale assessing general quality of life. It consists of self-administered 36-item questionnaire that measured 8 health domains: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These 8 domains are also summarized as physical and mental component scores. The score for each domain and component score is the mean of the individual question scores, which are scaled from 0 (minimum) to 100 (maximum), where high scores in each dimension and high overall scores indicate a better quality of life.
Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12	Baseline (measurement at enrollment), Month 3, Month 6 and Month 12	The HAQ-DI41 assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 =no difficulty," 1 = "some difficulty," 2 = "much difficulty," and 3 = "unable to do". The disability index was computed by adding the scores for each of the components and dividing by the number of components with an available score. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Trial Locations

Locations (41): Algemeen Stedelijk Ziekenhuis
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Aalst, Belgium
AZ Sint-Jan
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Bruges, Belgium
Nova Reuma Społka Partnerska
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Genk, Belgium
Sygehus Vendsyssel Hospital
🇩🇰
Hjørring, Denmark
Turku University Hospital
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Turku, Finland
CHU Besançon - Hôpital Jean Minjoz
🇫🇷
Besançon, France
Centre Hospitalier Jean Rougier
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Cahors, France
Infirmerie Protestante de Lyon
🇫🇷
Caluire-et-Cuire, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
🇫🇷
Clermont-Ferrand, France
Hopital Pasteur
🇫🇷
Nice, France
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Algemeen Stedelijk Ziekenhuis
🇧🇪Aalst, Belgium