Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Drug: Disease-modifying antirheumatic drug
- Registration Number
- NCT01039688
- Lead Sponsor
- Pfizer
- Brief Summary
This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 956
- Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
- Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
- Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL
- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
- History of any other rheumatic autoimmune disease other than Sjogren's syndrome
- No malignancy or history of malignancy
- History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
- No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 mg BID CP-690,550 CP-690,550 - 10 mg BID CP-690,550 CP-690,550 - methotrexate Disease-modifying antirheumatic drug -
- Primary Outcome Measures
Name Time Method Modified Total Sharp Score (mTSS) at Month 6 Month 6 mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Change From Baseline at Month 6 in mTSS Month 6 mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 Month 6 ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire \[HAQ\]), and 5) C-reactive protein (CRP).
Absolute Blood Pressure (BP) Values (mmHg) Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24 BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Change From Baseline in BP Values (mmHg) Months 1, 2, 3, 6, 9, 12, 15, 18, and 24 BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
- Secondary Outcome Measures
Name Time Method mTSS Score at Baseline, Months 12 and 24 Baseline, Months 12 and 24 mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 Months 6, 12, and 24 mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 Months 6, 12, and 24 Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
Erosion Scores Baseline, Months 6, 12, and 24 Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
Percentage of Participants Achieving an ACR50 Response Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Tender Joints Count (TJC) Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (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); 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).
Change From Baseline in mTSS Score at Months 12 and 24 Months 12 and 24 mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Change From Baseline in TJC Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
JSN Scores Baseline, Months 6, 12, and 24 JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
Change From Baseline in Erosion Scores Months 6, 12, and 24 Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in JSN Scores Months 6, 12, and 24 JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Percentage of Participants Achieving an ACR70 Response Months 1, 2, 3, 9, 12, 15, 18, 21, and 24 ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants Achieving an ACR20 Response Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Swollen Joints Count (SJC) Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Change From Baseline in SJC Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Change From Baseline in Physician Global Assessment of Arthritis Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Change From Baseline in Patient Global Assessment of Arthritis Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Patient Assessment of Arthritis Pain Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.
Physician Global Assessment of Arthritis Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Change From Baseline in CRP Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Change from Baseline in CRP measured in mg/L.
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) less than (\<)2.6 = remission.
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour \[mm/hour\]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Change From Baseline in DAS28-3(CRP) Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Change From Baseline in Patient Assessment of Arthritis Pain Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.
Patient Global Assessment of Arthritis Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
C-Reactive Protein Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 CRP measured in milligrams per liter (mg/L)
Change From Baseline in DAS28-4(ESR) Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Percentage of Participants With DAS28-3(CRP) ≤3.2 Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Percentage of Participants With DAS28-4(ESR) ≤3.2 Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Percentage of Participants With DAS28-3(CRP) <2.6 Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Percentage of Participants With DAS28-4(ESR) <2.6 Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline \[BL\]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits Months 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Change From Baseline in HAQ-DI Score Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Short Form 36 (SF-36) Mental Component Score Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months Months 6, 9, 12, 15, 18, 21, and 24 ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits Months 3, 6, 9, 12, 15, 18, 21, and 24 ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits Months 3, 6, 9, 12, 15, 18, 21, and 24 ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits Months 3, 6, 9, 12, 15, 18, 21, and 24 ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits Months 3, 6, 9, 12, 15, 18, 21, and 24 DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
SF-36 Domain Scores Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Health Assessment Questionnaire Disability Index (HAQ-DI) Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
SF-36 Physical Component Score Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Change From Baseline in SF-36 Physical Component Score Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Change From Baseline in SF-36 Domain Scores Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Work Limitation Questionnaire (WLQ) Score Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Change From Baseline in WLQ Scores Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
WLQ Work Loss Index Score Baseline and Months 3, 6, and 12 WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
Change From Baseline in WLQ Work Loss Index Score Months 3, 6, 12, 15, 18, 21, and 24 WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
Change From Baseline in SF-36 Mental Component Score Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score Baseline and Months 3, 6, 12, 18, and 24 EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Change From Baseline in EQ-5D Health State Profile Utility Score Months 3, 6, 12, 18, and 24 EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 Baseline and Months 3 and 6 Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Baseline and Months 3 and 6 RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Baseline and Months 3 and 6 RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 Baseline and Months 3 and 6 RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Baseline, Months 3, 6, 12, 18, and 24 Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Change From Baseline in Work Productivity and HCRU at Months 3 and 6 Months 3 and 6 RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 Months 3 and 6 RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 Months 3 and 6 RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 Months 3 and 6 RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 Months 12, 18, and 24 RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU Months 3, 6, 12, 18, and 24 Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 Baseline and Months 1, 2, and 3 Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS Months 1, 2, 3, 6, 12, 18, and 24 MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 Months 6, 12, 18, and 24 Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Change From Baseline in MOS-SS at Months 1, 2, and 3 Months 1, 2, and 3 Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 Months 6, 12, 18, and 24 Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Baseline and Months 1, 2, 3, 6, 12, 18, and 24 FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Change From Baseline in FACIT-Fatigue Scale Months 1, 2, 3, 6, 12, 18, and 24 FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Change From Baseline in Heart Rate Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 Change From Baseline in Temperature Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Trial Locations
- Locations (173)
Catalina Pointe Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Little Rock Diagnostic Clinic
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Perlman Ambulatory Clinic
🇺🇸La Jolla, California, United States
University of California San Diego Center for Innovative Therapy
🇺🇸La Jolla, California, United States
Keck Hospital of USC, Lower Level Pharmacy
🇺🇸Los Angeles, California, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
USC Keck School of Medicine
🇺🇸Los Angeles, California, United States
University of California Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Southeastern Arthritis Center
🇺🇸Gainesville, Florida, United States
Southeastern Imaging and Diagnostics
🇺🇸Gainesville, Florida, United States
Scroll for more (163 remaining)Catalina Pointe Clinical Research, Inc.🇺🇸Tucson, Arizona, United States