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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00960440
Registration number
NCT00960440
Ethics application status
Date submitted
14/08/2009
Date registered
17/08/2009
Date last updated
19/12/2018
Titles & IDs
Public title
Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
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Scientific title
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
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Secondary ID [1]
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A3921032
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - Placebo
Treatment: Drugs - CP-690,550
Treatment: Drugs - Placebo
Treatment: Drugs - CP-690,550
Experimental: Sequence 1 -
Experimental: Sequence 2 -
Placebo Comparator: Sequence 3 -
Placebo Comparator: Sequence 4 -
Treatment: Drugs: CP-690,550
Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
Treatment: Drugs: CP-690,550
Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
Treatment: Drugs: Placebo
Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
Treatment: Drugs: CP-690,550
Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
Treatment: Drugs: Placebo
Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
Treatment: Drugs: CP-690,550
Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
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Assessment method [1]
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ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
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Timepoint [1]
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Month 3
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Primary outcome [2]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
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Assessment method [2]
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; 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;3=unable to do. 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. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
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Timepoint [2]
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Baseline, Month 3
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Primary outcome [3]
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Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
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Assessment method [3]
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DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
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Timepoint [3]
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Month 3
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Secondary outcome [1]
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
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Assessment method [1]
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ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [1]
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Week 2, Month 1
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Secondary outcome [2]
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
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Assessment method [2]
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ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [2]
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Month 4.5, 6
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Secondary outcome [3]
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
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Assessment method [3]
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ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [3]
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Week 2, Month 1, 3
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Secondary outcome [4]
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
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Assessment method [4]
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ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [4]
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Month 4.5 and 6
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Secondary outcome [5]
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
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Assessment method [5]
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ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [5]
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Week 2, Month 1, 3
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Secondary outcome [6]
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6
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Assessment method [6]
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ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
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Timepoint [6]
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Month 4.5, 6
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Secondary outcome [7]
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
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Assessment method [7]
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DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
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Timepoint [7]
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Baseline, Week 2, Month 1, 3
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Secondary outcome [8]
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
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Assessment method [8]
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DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
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Timepoint [8]
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Month 4.5, 6
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Secondary outcome [9]
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Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
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Assessment method [9]
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DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
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Timepoint [9]
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Baseline, Month 3
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Secondary outcome [10]
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Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
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Assessment method [10]
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DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
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Timepoint [10]
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Month 6
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Secondary outcome [11]
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Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
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Assessment method [11]
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; 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; 3=unable to do. 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.
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Timepoint [11]
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Week 2, Month 1, 3
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Secondary outcome [12]
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Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6
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Assessment method [12]
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; 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; 3=unable to do. 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.
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Timepoint [12]
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Month 4.5, 6
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Secondary outcome [13]
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Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
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Assessment method [13]
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Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
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Timepoint [13]
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Baseline, Week 2, Month 1, 3
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Secondary outcome [14]
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Patient Assessment of Arthritis Pain at Month 4.5 and 6
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Assessment method [14]
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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.
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Timepoint [14]
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Month 4.5, 6
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Secondary outcome [15]
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Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
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Assessment method [15]
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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 mm = very well and 100 mm = very poorly.
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Timepoint [15]
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Baseline, Week 2, Month 1, 3
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Secondary outcome [16]
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Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6
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Assessment method [16]
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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 mm = very well and 100 mm = very poorly.
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Timepoint [16]
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Month 4.5, 6
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Secondary outcome [17]
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Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
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Assessment method [17]
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Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
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Timepoint [17]
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Baseline, Week 2, Month 1, 3
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Secondary outcome [18]
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Physician Global Assessment of Arthritis at Month 4.5 and 6
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Assessment method [18]
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Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
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Timepoint [18]
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Month 4.5, 6
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Secondary outcome [19]
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36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
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Assessment method [19]
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SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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).
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Timepoint [19]
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Baseline, Week 2, Month 1, 3
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Secondary outcome [20]
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36-Item Short-Form Health Survey (SF-36) at Month 6
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Assessment method [20]
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SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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).
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Timepoint [20]
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Month 6
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Secondary outcome [21]
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Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
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Assessment method [21]
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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/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=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.
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Timepoint [21]
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Baseline, Week 2, Month 1, 3
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Secondary outcome [22]
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Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
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Assessment method [22]
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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/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=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.
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Timepoint [22]
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Month 6
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Secondary outcome [23]
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Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
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Assessment method [23]
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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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
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Timepoint [23]
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Baseline, Week 2, Month 1, 3
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Secondary outcome [24]
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Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
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Assessment method [24]
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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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
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Timepoint [24]
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Month 6
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Secondary outcome [25]
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Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
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Assessment method [25]
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FACIT-Fatigue Scale (FS):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-FS 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.
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Timepoint [25]
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Baseline, Month 3
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Secondary outcome [26]
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Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
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Assessment method [26]
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FACIT-FS: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-FS 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.
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Timepoint [26]
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Month 6
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Secondary outcome [27]
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Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
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Assessment method [27]
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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.
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Timepoint [27]
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Baseline, Month 1, 3
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Secondary outcome [28]
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Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6
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Assessment method [28]
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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.
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Timepoint [28]
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Month 6
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Secondary outcome [29]
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Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
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Assessment method [29]
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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, over-night 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.
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Timepoint [29]
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Baseline, Month 3
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Secondary outcome [30]
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Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
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Assessment method [30]
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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, over-night 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.
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Timepoint [30]
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Month 6
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Secondary outcome [31]
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Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
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Assessment method [31]
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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.
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Timepoint [31]
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0
Baseline, Month 3
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Secondary outcome [32]
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0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
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Assessment method [32]
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0
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.
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Timepoint [32]
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0
Month 6
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Secondary outcome [33]
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Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
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Assessment method [33]
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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 were reported.
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Timepoint [33]
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0
Baseline, Month 3
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Secondary outcome [34]
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Number of Days as Assessed Using RA-HCRU at Month 6
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Assessment method [34]
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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 were reported.
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Timepoint [34]
0
0
Month 6
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Secondary outcome [35]
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Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
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Assessment method [35]
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RA-HCRU assessed healthcare 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, hours affected per day and average number of hours missed work per day were reported.
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Timepoint [35]
0
0
Baseline, Month 3
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Secondary outcome [36]
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0
Number of Hours Per Day as Assessed RA-HCRU at Month 6
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Assessment method [36]
0
0
RA-HCRU assessed healthcare 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, hours affected per day and average number of hours missed work per day were reported.
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Timepoint [36]
0
0
Month 6
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Secondary outcome [37]
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0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
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Assessment method [37]
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0
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
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Timepoint [37]
0
0
Baseline, Month 3
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Secondary outcome [38]
0
0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
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Assessment method [38]
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Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
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Timepoint [38]
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0
Month 6
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Secondary outcome [39]
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Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
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Assessment method [39]
0
0
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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]).
Query!
Timepoint [39]
0
0
Baseline, Month 3
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Secondary outcome [40]
0
0
Work Limitations Questionnaire (WLQ) Score at Month 6
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Assessment method [40]
0
0
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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]).
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Timepoint [40]
0
0
Month 6
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Eligibility
Key inclusion criteria
- Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate
who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.
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Minimum age
18
Years
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Query!
Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnancy, severe acute or chronic medical conditions, including serious infections or
clinically significant laboratory abnormalities.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Query!
Query!
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2009
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Date of last participant enrolment
Anticipated
Query!
Actual
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Date of last data collection
Anticipated
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Actual
1/03/2011
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Sample size
Target
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Accrual to date
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Final
399
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
0
0
Pfizer Investigational Site - Kogarah
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Recruitment hospital [2]
0
0
Pfizer Investigational Site - Daw Park
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Recruitment hospital [3]
0
0
Pfizer Investigational Site - Heidelberg
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Recruitment postcode(s) [1]
0
0
2217 - Kogarah
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Recruitment postcode(s) [2]
0
0
5041 - Daw Park
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Recruitment postcode(s) [3]
0
0
3081 - Heidelberg
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Connecticut
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Idaho
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Indiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Louisiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Maine
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Maryland
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Massachusetts
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Mississippi
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New Hampshire
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Country [15]
0
0
United States of America
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State/province [15]
0
0
New Jersey
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Country [16]
0
0
United States of America
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State/province [16]
0
0
North Carolina
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Pennsylvania
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Tennessee
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Texas
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Washington
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Country [21]
0
0
Austria
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State/province [21]
0
0
Wien
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Country [22]
0
0
Belgium
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State/province [22]
0
0
Genk
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Country [23]
0
0
Belgium
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State/province [23]
0
0
Hasselt
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Country [24]
0
0
Belgium
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State/province [24]
0
0
Kortrijk
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Country [25]
0
0
Belgium
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State/province [25]
0
0
Liège
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Country [26]
0
0
Brazil
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State/province [26]
0
0
GO
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Country [27]
0
0
Brazil
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State/province [27]
0
0
PR
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Country [28]
0
0
Brazil
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State/province [28]
0
0
RS
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Country [29]
0
0
Brazil
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State/province [29]
0
0
SP
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Country [30]
0
0
Canada
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State/province [30]
0
0
Manitoba
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Country [31]
0
0
Canada
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State/province [31]
0
0
Ontario
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Country [32]
0
0
Canada
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State/province [32]
0
0
Quebec
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Country [33]
0
0
France
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State/province [33]
0
0
Amiens
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Country [34]
0
0
France
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State/province [34]
0
0
Lyon
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Country [35]
0
0
France
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State/province [35]
0
0
Orleans Cedex 1
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Country [36]
0
0
France
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State/province [36]
0
0
Orleans
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Country [37]
0
0
France
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State/province [37]
0
0
Paris
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Country [38]
0
0
Germany
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State/province [38]
0
0
Berlin
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Country [39]
0
0
Germany
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State/province [39]
0
0
Erlangen
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Country [40]
0
0
Germany
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State/province [40]
0
0
Frankfurt am Main
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Country [41]
0
0
Germany
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State/province [41]
0
0
Halle
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Country [42]
0
0
Germany
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State/province [42]
0
0
Hamburg
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Country [43]
0
0
Germany
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State/province [43]
0
0
Koeln
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Country [44]
0
0
Germany
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State/province [44]
0
0
Leipzig
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Country [45]
0
0
Germany
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State/province [45]
0
0
Rheine
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Country [46]
0
0
Germany
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State/province [46]
0
0
Wuerzburg
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Country [47]
0
0
Ireland
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State/province [47]
0
0
Co. Limerick
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Country [48]
0
0
Ireland
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State/province [48]
0
0
Dublin
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Country [49]
0
0
Italy
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State/province [49]
0
0
Firenze
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Country [50]
0
0
Italy
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State/province [50]
0
0
Jesi
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Country [51]
0
0
Korea, Republic of
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State/province [51]
0
0
Busan
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Country [52]
0
0
Korea, Republic of
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State/province [52]
0
0
Daegu
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Country [53]
0
0
Korea, Republic of
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State/province [53]
0
0
Seoul
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Country [54]
0
0
Puerto Rico
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State/province [54]
0
0
San Juan
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Country [55]
0
0
Spain
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State/province [55]
0
0
A Coruña
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Country [56]
0
0
Spain
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State/province [56]
0
0
Badajoz
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Country [57]
0
0
Spain
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State/province [57]
0
0
Bizkaia
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Country [58]
0
0
Spain
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State/province [58]
0
0
Cantabria
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Country [59]
0
0
Spain
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State/province [59]
0
0
Vizcaya
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Country [60]
0
0
Spain
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State/province [60]
0
0
Madrid
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Country [61]
0
0
Spain
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State/province [61]
0
0
Valencia
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Country [62]
0
0
Taiwan
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State/province [62]
0
0
Kaohsiung County
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Country [63]
0
0
Taiwan
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State/province [63]
0
0
Taoyuan County
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Country [64]
0
0
Taiwan
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State/province [64]
0
0
Changhua
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Country [65]
0
0
Taiwan
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State/province [65]
0
0
Kaohsiung
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients
taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor
treatment.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00960440
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Query!
Address
0
0
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00960440
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