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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00856544




Registration number
NCT00856544
Ethics application status
Date submitted
3/03/2009
Date registered
3/03/2009
Date last updated
6/12/2012

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
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
Secondary ID [1] 0 0
A3921046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 - 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.
Timepoint [1] 0 0
Month 6
Primary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 - 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.
Timepoint [2] 0 0
Baseline, Month 3
Primary outcome [3] 0 0
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 - 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.
Timepoint [3] 0 0
Month 6
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 - 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.
Timepoint [1] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 - 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.
Timepoint [2] 0 0
Month 9, 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 - 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.
Timepoint [3] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 - 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.
Timepoint [4] 0 0
Month 9, 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 - 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.
Timepoint [5] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [6] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 - 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.
Timepoint [6] 0 0
Month 9, 12
Secondary outcome [7] 0 0
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 - 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.
Timepoint [7] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [8] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 - 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.
Timepoint [8] 0 0
Month 9, 12
Secondary outcome [9] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 - 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.
Timepoint [9] 0 0
Baseline, Month 3, 6
Secondary outcome [10] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12 - 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.
Timepoint [10] 0 0
Month 12
Secondary outcome [11] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) - 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.
Timepoint [11] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
Secondary outcome [12] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) - 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.
Timepoint [12] 0 0
Baseline, Month 3, 6, 12
Secondary outcome [13] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 - 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.
Timepoint [13] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [14] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 - 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.
Timepoint [14] 0 0
Month 9, Month 12
Secondary outcome [15] 0 0
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 - 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.
Timepoint [15] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [16] 0 0
Patient Assessment of Arthritis Pain at Month 9 and 12 - 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.
Timepoint [16] 0 0
Month 9, 12
Secondary outcome [17] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 - 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.
Timepoint [17] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [18] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 - 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.
Timepoint [18] 0 0
Month 9, 12
Secondary outcome [19] 0 0
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 - Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Timepoint [19] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [20] 0 0
Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 - Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Timepoint [20] 0 0
Month 9, 12
Secondary outcome [21] 0 0
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 - 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.
Timepoint [21] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [22] 0 0
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 - 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.
Timepoint [22] 0 0
Month 9, 12
Secondary outcome [23] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 - 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.
Timepoint [23] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [24] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 - 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.
Timepoint [24] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [25] 0 0
Medical Outcome Study (MOS) Sleep Scale at Month 12 - 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.
Timepoint [25] 0 0
Month 12
Secondary outcome [26] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12 - 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.
Timepoint [26] 0 0
Month 12
Secondary outcome [27] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 - 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.
Timepoint [27] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [28] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 - 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.
Timepoint [28] 0 0
Month 12
Secondary outcome [29] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 - 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.
Timepoint [29] 0 0
Baseline, Month 3, 6
Secondary outcome [30] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12 - 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.
Timepoint [30] 0 0
Month 12
Secondary outcome [31] 0 0
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 - 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]).
Timepoint [31] 0 0
Baseline, Month 3, 6
Secondary outcome [32] 0 0
Work Limitations Questionnaire (WLQ) Score at Month 12 - WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Timepoint [32] 0 0
Month 12
Secondary outcome [33] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 - Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, 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.
Timepoint [33] 0 0
Baseline, Month 3, 6
Secondary outcome [34] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 - 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.
Timepoint [34] 0 0
Month 12
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 - 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.
Timepoint [35] 0 0
Baseline, Month 3, 6
Secondary outcome [36] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 - 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.
Timepoint [36] 0 0
Month 12
Secondary outcome [37] 0 0
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 - RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Timepoint [37] 0 0
Baseline, Month 3, 6
Secondary outcome [38] 0 0
Number of Days as Assessed Using RA-HCRU at Month 12 - 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.
Timepoint [38] 0 0
Month 12
Secondary outcome [39] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 - RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of 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.
Timepoint [39] 0 0
Baseline, Month 3, 6
Secondary outcome [40] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Month 12 - 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.
Timepoint [40] 0 0
Month 12
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 - 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.
Timepoint [41] 0 0
Baseline, Month 3, 6
Secondary outcome [42] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 - 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.
Timepoint [42] 0 0
Month 12

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Campsie
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Cairns
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woodville
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Malvern East
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Shenton Park
Recruitment postcode(s) [1] 0 0
2194 - Campsie
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3145 - Malvern East
Recruitment postcode(s) [6] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
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Distrito Capital

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00856544
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications