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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00853385




Registration number
NCT00853385
Ethics application status
Date submitted
27/02/2009
Date registered
27/02/2009
Date last updated
10/01/2013

Titles & IDs
Public title
A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Scientific title
Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Secondary ID [1] 0 0
A3921064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 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
Other interventions - Placebo
Other interventions - Placebo
Other interventions - Biologic TNFi

Experimental: 5mg -

Experimental: 10 mg -

Placebo Comparator: Placebo Sequence 1 -

Placebo Comparator: Placebo Sequence 2 -

Active Comparator: adalimumab -


Treatment: Drugs: CP 690,550
tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months

Treatment: Drugs: CP-690,550
tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months

Other interventions: Placebo
placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Other interventions: Placebo
tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Other interventions: Biologic TNFi
placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
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% 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 the Health Assessment Questionnaire-Disability Index (HAQ-DI) 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 With 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) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (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) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 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) Response at Month 1 and 3 - ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Timepoint [1] 0 0
Month 1, 3
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response 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 the 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) Response at Month 1, 3 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 the HAQ); and CRP.
Timepoint [3] 0 0
Month 1, 3, 6
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response 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 the 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) Response at Month 1, 3 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 the HAQ); and CRP.
Timepoint [5] 0 0
Month 1, 3, 6
Secondary outcome [6] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response 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 the 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, Month 1, 3 and 6 - DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [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
Baseline, Month 1, 3, 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 1, 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 1, 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 9 and 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 9, 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] calculated from SJC and TJC using 28 joint count, CRP (mg/L) 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 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Timepoint [11] 0 0
Baseline, Month 1, 3, 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 SJC and TJC using 28 joint count and ESR (mm/hour). 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 1, 3, 6, 9, 12
Secondary outcome [13] 0 0
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 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; 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.
Timepoint [13] 0 0
Month 1, 3, 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; 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.
Timepoint [14] 0 0
Month 9, 12
Secondary outcome [15] 0 0
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 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, Month 1, 3, 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, Month 1, 3 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 mm = very well and 100 mm = very poorly.
Timepoint [17] 0 0
Baseline, Month 1, 3, 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 mm = very well and 100 mm = very poorly.
Timepoint [18] 0 0
Month 9, 12
Secondary outcome [19] 0 0
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 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, Month 1, 3, 6
Secondary outcome [20] 0 0
Physician Global Assessment (PGA) of Arthritis Pain 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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented 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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Timepoint [22] 0 0
Month 9, 12
Secondary outcome [23] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 - FACIT-Fatigue scale 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 [23] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [24] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 - FACIT-Fatigue scale 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 [24] 0 0
Month 12
Secondary outcome [25] 0 0
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 - Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Timepoint [25] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [26] 0 0
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 - Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Timepoint [26] 0 0
Month 12
Secondary outcome [27] 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 [27] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [28] 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 [28] 0 0
Month 12
Secondary outcome [29] 0 0
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 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 1, 3, 6
Secondary outcome [30] 0 0
Euro Quality of Life-5 Dimension (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 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Timepoint [31] 0 0
Month 3, 6
Secondary outcome [32] 0 0
Work Limitations Questionnaire (WLQ) Score at Baseline and 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Timepoint [32] 0 0
Baseline, 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: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) 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 indicated 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 - RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and 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 indicated 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, hours affected per day and average number of hours missed work per day 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, hours affected per day and average number of hours missed work per day 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 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 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 RA based upon the American College of Rheumatology
(ACR) 1987 Revised Criteria.

- The patient must have had an inadequate response to methotrexate and have active
disease, as defined by both: =6 joints tender or painful on motion; and =6 joints
swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren
method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.

- No evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis.

- The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate
and washed out of all other DMARDs.
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: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2.
White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4.
Platelet count <100,000/L

- History of any other autoimmune rheumatic 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

- Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism
related adverse event.

- Patients who have previously received adalimumab therapy for any reason.

- Patients who are contraindicated for treatment with adalimumab in accordance with the
approved local label.

- Patients meeting the New York Heart Association Class III and Class IV Congestive
Heart failure

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,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - St Leonards
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 - Malvern East
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
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Dudley, West Midlands

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background
methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence
of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background
methotrexate in adult patients with moderate to severe 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 Rheumatoid Arthritis. An active comparator, adalimumab, is also
included.
Trial website
https://clinicaltrials.gov/show/NCT00853385
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
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications