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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00856544
Registration number
NCT00856544
Ethics application status
Date submitted
3/03/2009
Date registered
5/03/2009
Date last updated
10/01/2013
Titles & IDs
Public title
A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
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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 DMARDS
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Secondary ID [1]
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A3921046
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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 - Placebo
Experimental: Active 5 mg -
Experimental: Active 10 mg -
Placebo comparator: Placebo Sequence 1 - Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
Placebo comparator: Placebo Sequence 2 - Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
Treatment: Drugs: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Treatment: Drugs: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Treatment: Drugs: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Treatment: Drugs: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
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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 6
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Assessment method [1]
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ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint 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 6 analysis.
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Timepoint [1]
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Month 6
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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 Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
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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) (millimeters/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 6 analysis.
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Timepoint [3]
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Month 6
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Secondary outcome [1]
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [1]
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ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; 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 HAQ); and CRP.
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Timepoint [1]
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Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [2]
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
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Assessment method [2]
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ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; 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 HAQ); and CRP.
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Timepoint [2]
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Month 9, 12
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Secondary outcome [3]
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [3]
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ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; 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 HAQ); and CRP.
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Timepoint [3]
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Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [4]
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
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Assessment method [4]
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ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; 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 HAQ); and CRP.
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Timepoint [4]
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Month 9, 12
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Secondary outcome [5]
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [5]
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ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; 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 HAQ); and CRP.
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Timepoint [5]
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Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [6]
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
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Assessment method [6]
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ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; 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 HAQ); and CRP.
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Timepoint [6]
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Month 9, 12
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Secondary outcome [7]
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Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [7]
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DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint 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, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
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Timepoint [7]
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Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [8]
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Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
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Assessment method [8]
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DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint 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, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
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Timepoint [8]
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Month 9, 12
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Secondary outcome [9]
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6
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Assessment method [9]
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DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
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Timepoint [9]
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Baseline, Month 3, 6
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Secondary outcome [10]
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
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Assessment method [10]
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DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
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Timepoint [10]
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Month 12
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Secondary outcome [11]
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Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
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Assessment method [11]
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DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP \[mg/L\] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 \[CRP\] \<=3.2 implied low disease activity, DAS28-4 \[CRP\] \>3.2 to 5.1 implied moderate to high disease activity and DAS28 \<2.6 implied remission.
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Timepoint [11]
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
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Secondary outcome [12]
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
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Assessment method [12]
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DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
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Timepoint [12]
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0
Baseline, Month 3, 6, 12
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Secondary outcome [13]
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Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [13]
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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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
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Timepoint [13]
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [14]
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Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
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Assessment method [14]
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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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
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Timepoint [14]
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Month 9, Month 12
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Secondary outcome [15]
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Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [16]
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Patient Assessment of Arthritis Pain at Month 9 and 12
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Assessment method [16]
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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 [16]
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Month 9, 12
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Secondary outcome [17]
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Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [17]
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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 = very well and 100 = very poorly.
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Timepoint [17]
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [18]
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Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
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Assessment method [18]
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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 = very well and 100 = very poorly.
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Timepoint [18]
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Month 9, 12
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Secondary outcome [19]
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Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
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Assessment method [19]
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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 [19]
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Secondary outcome [20]
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Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
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Assessment method [20]
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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 [20]
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Month 9, 12
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Secondary outcome [21]
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36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline, Month 1, 3, 6
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Secondary outcome [22]
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36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
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Assessment method [22]
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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.
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Timepoint [22]
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Month 9, 12
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Secondary outcome [23]
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Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
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Assessment method [23]
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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 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 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 [23]
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Baseline, Month 1, 3, 6
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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 Baseline, Month 1, 3 and 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 by choosing yes or no. Number of participants with optimal sleep are reported.
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Timepoint [24]
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Baseline, Month 1, 3, 6
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Secondary outcome [25]
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Medical Outcome Study (MOS) Sleep Scale at Month 12
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Assessment method [25]
0
0
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 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 [25]
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Month 12
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Secondary outcome [26]
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Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
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Assessment method [26]
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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 by choosing yes or no. Number of participants with optimal sleep are reported.
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Timepoint [26]
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0
Month 12
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Secondary outcome [27]
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0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
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Assessment method [27]
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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.
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Timepoint [27]
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0
Baseline, Month 1, 3, 6
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Secondary outcome [28]
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Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
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Assessment method [28]
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0
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.
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Timepoint [28]
0
0
Month 12
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Secondary outcome [29]
0
0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6
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Assessment method [29]
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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 [29]
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0
Baseline, Month 3, 6
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Secondary outcome [30]
0
0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
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Assessment method [30]
0
0
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 [30]
0
0
Month 12
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Secondary outcome [31]
0
0
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
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Assessment method [31]
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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 (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\[complete loss of work\]).
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Timepoint [31]
0
0
Baseline, Month 3, 6
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Secondary outcome [32]
0
0
Work Limitations Questionnaire (WLQ) Score at Month 12
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Assessment method [32]
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 (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\[complete loss of work\]).
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Timepoint [32]
0
0
Month 12
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Secondary outcome [33]
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0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
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Assessment method [33]
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0
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 [33]
0
0
Baseline, Month 3, 6
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Secondary outcome [34]
0
0
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
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Assessment method [34]
0
0
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.
Query!
Timepoint [34]
0
0
Month 12
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Secondary outcome [35]
0
0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
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Assessment method [35]
0
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.
Query!
Timepoint [35]
0
0
Baseline, Month 3, 6
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Secondary outcome [36]
0
0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
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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/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.
Query!
Timepoint [36]
0
0
Month 12
Query!
Secondary outcome [37]
0
0
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Query!
Assessment method [37]
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 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.
Query!
Timepoint [37]
0
0
Baseline, Month 3, 6
Query!
Secondary outcome [38]
0
0
Number of Days as Assessed Using RA-HCRU at Month 12
Query!
Assessment method [38]
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 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.
Query!
Timepoint [38]
0
0
Month 12
Query!
Secondary outcome [39]
0
0
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Query!
Assessment method [39]
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, work done and work missed were reported.
Query!
Timepoint [39]
0
0
Baseline, Month 3, 6
Query!
Secondary outcome [40]
0
0
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Query!
Assessment method [40]
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, work done and work missed were reported.
Query!
Timepoint [40]
0
0
Month 12
Query!
Secondary outcome [41]
0
0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Query!
Assessment method [41]
0
0
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.
Query!
Timepoint [41]
0
0
Baseline, Month 3, 6
Query!
Secondary outcome [42]
0
0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Query!
Assessment method [42]
0
0
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.
Query!
Timepoint [42]
0
0
Month 12
Query!
Eligibility
Key inclusion criteria
* The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
* Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
* Patient must remain on at least one background traditional disease modifying antirheumatic drug.
* No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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!
Query!
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
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2009
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2011
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Sample size
Target
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Accrual to date
Query!
Final
795
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
0
0
Pfizer Investigational Site - Campsie
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Recruitment hospital [2]
0
0
Pfizer Investigational Site - Cairns
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Recruitment hospital [3]
0
0
Pfizer Investigational Site - Maroochydore
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Recruitment hospital [4]
0
0
Pfizer Investigational Site - Woodville
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Recruitment hospital [5]
0
0
Pfizer Investigational Site - Malvern East
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Recruitment hospital [6]
0
0
Pfizer Investigational Site - Shenton Park
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Recruitment postcode(s) [1]
0
0
2194 - Campsie
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Recruitment postcode(s) [2]
0
0
4870 - Cairns
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Recruitment postcode(s) [3]
0
0
4558 - Maroochydore
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Recruitment postcode(s) [4]
0
0
5011 - Woodville
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Recruitment postcode(s) [5]
0
0
3145 - Malvern East
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Recruitment postcode(s) [6]
0
0
6008 - Shenton Park
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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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0
0
United States of America
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0
0
Arkansas
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0
United States of America
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0
0
California
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0
United States of America
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0
0
Colorado
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0
United States of America
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0
Connecticut
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0
United States of America
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0
0
Florida
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0
United States of America
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0
Georgia
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United States of America
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Illinois
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0
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0
Indiana
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0
United States of America
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0
Kansas
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0
United States of America
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Kentucky
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0
United States of America
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0
0
Massachusetts
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0
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Minnesota
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0
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Nebraska
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0
United States of America
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New York
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0
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North Carolina
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Pennsylvania
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South Carolina
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0
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0
Tennessee
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0
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0
Texas
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0
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0
0
Washington
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0
0
United States of America
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0
0
West Virginia
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0
0
Chile
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State/province [23]
0
0
RM
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Country [24]
0
0
Chile
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State/province [24]
0
0
Santiago, RM
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0
0
Chile
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State/province [25]
0
0
V Region
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0
0
Chile
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State/province [26]
0
0
Vina del Mar
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0
China
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0
0
Anhui
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China
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Guangdong
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Shandong
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China
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Shanxi
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China
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Sichuan
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China
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Zhejiang
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China
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Beijing
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China
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Shanghai
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China
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Tianjin
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Colombia
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Atlantico
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0
Colombia
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0
Cundinamarca
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Colombia
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0
Santander
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Croatia
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Opatija
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Croatia
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Zagreb
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0
Denmark
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Frederiksberg
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Finland
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0
Helsinki
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0
Finland
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0
Hyvinkaa
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0
0
Finland
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0
0
Tampere
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0
0
Germany
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0
0
Berlin
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0
Germany
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0
Dresden
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0
Germany
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0
Hamburg
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0
0
Germany
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0
0
Leipzig
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0
0
Germany
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0
0
Nuernberg
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0
0
Germany
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State/province [53]
0
0
Rheine
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Country [54]
0
0
Greece
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State/province [54]
0
0
Maroussi Athens
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0
0
Malaysia
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State/province [55]
0
0
Negeri Sembilan
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Country [56]
0
0
Malaysia
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State/province [56]
0
0
Selangor
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Country [57]
0
0
Malaysia
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State/province [57]
0
0
Wilayah Persekutuan
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Country [58]
0
0
Mexico
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State/province [58]
0
0
Coahuila
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Country [59]
0
0
Mexico
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0
0
Michoacan
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0
0
Mexico
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0
0
Morelos
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Country [61]
0
0
Mexico
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0
0
Queretaro
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0
0
Mexico
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0
0
Yucatan
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Country [63]
0
0
Poland
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State/province [63]
0
0
Bialystok
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Country [64]
0
0
Poland
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State/province [64]
0
0
Koscian
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Country [65]
0
0
Poland
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State/province [65]
0
0
Poznan
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Country [66]
0
0
Poland
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State/province [66]
0
0
Torun
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Country [67]
0
0
Russian Federation
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State/province [67]
0
0
Moscow
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Country [68]
0
0
Russian Federation
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State/province [68]
0
0
Petrozavodsk
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Country [69]
0
0
Slovakia
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State/province [69]
0
0
Nove Zamky
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Country [70]
0
0
Slovakia
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State/province [70]
0
0
Poprad
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Country [71]
0
0
Slovakia
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State/province [71]
0
0
Povazska Bystrica
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Country [72]
0
0
Slovakia
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State/province [72]
0
0
Rimavska Sobota
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Country [73]
0
0
Slovakia
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State/province [73]
0
0
Senica
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Country [74]
0
0
Slovakia
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State/province [74]
0
0
Zilina
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Country [75]
0
0
Spain
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State/province [75]
0
0
A Coruña
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Country [76]
0
0
Spain
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State/province [76]
0
0
Madrid
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Country [77]
0
0
Spain
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State/province [77]
0
0
Malaga
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Country [78]
0
0
Spain
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State/province [78]
0
0
Sevilla
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Country [79]
0
0
Sweden
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State/province [79]
0
0
Falun
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Country [80]
0
0
Sweden
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State/province [80]
0
0
Goteborg
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Country [81]
0
0
Sweden
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State/province [81]
0
0
Uppsala
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Country [82]
0
0
Thailand
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State/province [82]
0
0
Bangkok
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Country [83]
0
0
Thailand
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State/province [83]
0
0
Chiang Mai
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Country [84]
0
0
Thailand
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State/province [84]
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0
Khonkaen
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Country [85]
0
0
United Kingdom
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State/province [85]
0
0
Merseyside
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Country [86]
0
0
United Kingdom
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State/province [86]
0
0
Staffs
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Country [87]
0
0
United Kingdom
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State/province [87]
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0
West Midlands
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Country [88]
0
0
United Kingdom
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State/province [88]
0
0
Newcastle Upon Tyne
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Country [89]
0
0
Venezuela
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State/province [89]
0
0
DC/ Municipio Libertados
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Country [90]
0
0
Venezuela
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State/province [90]
0
0
Distrito Capital
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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 Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.
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Trial website
https://clinicaltrials.gov/study/NCT00856544
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Trial related presentations / publications
Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103. Bartlett SJ, Bingham CO, van Vollenhoven R, Murray C, Gruben D, Gold DA, Cella D. The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials. Arthritis Res Ther. 2022 Apr 5;24(1):83. doi: 10.1186/s13075-022-02724-x. Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17. Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6. Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395. Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7. Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z. Li ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157. Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19. Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11. Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31. Strand V, Kremer JM, Gruben D, Krishnaswami S, Zwillich SH, Wallenstein GV. Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Apr;69(4):592-598. doi: 10.1002/acr.23004. Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611. doi: 10.1136/annrheumdis-2014-207178corr1. Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779. Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, Isaacs JD, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Riese R, Bradley J. Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):253-61. doi: 10.7326/0003-4819-159-4-201308200-00006.
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Public notes
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Contacts
Principal investigator
Name
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0
Pfizer CT.gov Call Center
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Address
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Pfizer
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0
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Phone
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0
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Contact person for public queries
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT00856544
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