A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00853385

Recruitment Status : Completed

First Posted : March 2, 2009

Results First Posted : January 9, 2013

Last Update Posted : January 18, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: CP 690,550 Drug: CP-690,550 Other: Placebo Biological: Biologic TNFi	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	717 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official 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
Study Start Date :	May 2009
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 5mg	Drug: CP 690,550 tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
Experimental: 10 mg	Drug: CP-690,550 tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
Placebo Comparator: Placebo Sequence 1	Other: 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
Placebo Comparator: Placebo Sequence 2	Other: 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
Active Comparator: adalimumab	Biological: Biologic TNFi placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months Other Name: Humira (Adalimumab)

Outcome Measures

Primary Outcome Measures :

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 [ Time Frame: 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.
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 [ Time Frame: Baseline, 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.
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 [ Time Frame: 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.

Secondary Outcome Measures :

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 [ Time Frame: Month 1, 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.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 [ Time Frame: Month 9, 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.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 [ Time Frame: Month 1, 3, 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.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 [ Time Frame: Month 9, 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.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 [ Time Frame: Month 1, 3, 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.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 [ Time Frame: Month 9, 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.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 [ Time Frame: Month 9, 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.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 [ Time Frame: Month 9, 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.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]
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.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]
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.
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 [ Time Frame: Month 1, 3, 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.
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 [ Time Frame: Month 9, 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.
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Patient Assessment of Arthritis Pain at Month 9 and 12 [ Time Frame: Month 9, 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.
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 [ Time Frame: Month 9, 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.
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 [ Time Frame: Month 9, 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.
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 [ Time Frame: Month 9, 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.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 [ Time Frame: 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.
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 [ Time Frame: 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.
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 [ Time Frame: 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.
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 [ Time Frame: Baseline, Month 1, 3, 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.
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 [ Time Frame: 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.
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 [ Time Frame: Month 3, 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]).
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 [ Time Frame: Baseline, 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]).
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 [ Time Frame: Baseline, Month 3, 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.
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 [ Time Frame: 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.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [ Time Frame: Baseline, Month 3, 6 ]
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 [ Time Frame: 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.
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [ Time Frame: Baseline, Month 3, 6 ]
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Number of Days as Assessed Using RA-HCRU at Month 12 [ Time Frame: 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.
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 [ Time Frame: Baseline, Month 3, 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.
Number of Hours Per Day as Assessed RA-HCRU at Month 12 [ Time Frame: 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.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [ Time Frame: Baseline, Month 3, 6 ]
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 [ Time Frame: Month 12 ]
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853385

Locations

Show 125 study locations

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United States, Arizona
Pfizer Investigational Site
Gilbert, Arizona, United States, 85234
Pfizer Investigational Site
Glendale, Arizona, United States, 85304
Pfizer Investigational Site
Mesa, Arizona, United States, 85202
Pfizer Investigational Site
Paradise Valley, Arizona, United States, 85253
Pfizer Investigational Site
Phoenix, Arizona, United States, 85037
United States, Arkansas
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
Pfizer Investigational Site
Fair Oaks, California, United States, 95628
Pfizer Investigational Site
San Diego, California, United States, 92108
United States, Colorado
Pfizer Investigational Site
Boulder, Colorado, United States, 80304
United States, Florida
Pfizer Investigational Site
Largo, Florida, United States, 33777
Pfizer Investigational Site
Naples, Florida, United States, 34102
Pfizer Investigational Site
Palm Harbor, Florida, United States, 34684
Pfizer Investigational Site
Pinellas Park, Florida, United States, 33782
Pfizer Investigational Site
Plantation, Florida, United States, 33324
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33710
Pfizer Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
Pfizer Investigational Site
Rockford, Illinois, United States, 61107
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47714
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67203
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40504
Pfizer Investigational Site
Lexington, Kentucky, United States, 40515
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70809
United States, Massachusetts
Pfizer Investigational Site
Haverhill, Massachusetts, United States, 01830
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Michigan
Pfizer Investigational Site
Grand Rapids, Michigan, United States, 49546
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29601
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Houston, Texas, United States, 77034
Pfizer Investigational Site
Lubbock, Texas, United States, 79424
Pfizer Investigational Site
Mesquite, Texas, United States, 75150
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Pfizer Investigational Site
Seattle, Washington, United States, 98122
United States, West Virginia
Pfizer Investigational Site
Clarksburg, West Virginia, United States, 26301
Australia, New South Wales
Pfizer Investigational Site
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Pfizer Investigational Site
Cairns, Queensland, Australia, 4870
Pfizer Investigational Site
Maroochydore, Queensland, Australia, 4558
Australia, Victoria
Pfizer Investigational Site
Malvern East, Victoria, Australia, 3145
Bosnia and Herzegovina
Pfizer Investigational Site
Sarajevo, Bosnia and Herzegovina, 71000
Bulgaria
Pfizer Investigational Site
Pleven, Bulgaria, 5800
Pfizer Investigational Site
Plovdiv, Bulgaria, 4000
Pfizer Investigational Site
Plovdiv, Bulgaria, 4002
Pfizer Investigational Site
Sevlievo, Bulgaria, 5400
Pfizer Investigational Site
Sofia, Bulgaria, 1606
Pfizer Investigational Site
Sofia, Bulgaria, 1709
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1L7
Canada, Nova Scotia
Pfizer Investigational Site
Lunenburg, Nova Scotia, Canada, B0J 2C0
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4V2
Pfizer Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
Pfizer Investigational Site
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Pfizer Investigational Site
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Pfizer Investigational Site
Quebec, Canada, G1W 4R4
Chile
Pfizer Investigational Site
Santiago, RM, Chile, 7510186
Pfizer Investigational Site
Santiago, RM, Chile, 8360156
Pfizer Investigational Site
Providencia, Santiago, RM, Chile, 7530206
Pfizer Investigational Site
Rancagua, VI Region, Chile, 2841959
Costa Rica
Pfizer Investigational Site
Cartago, Costa Rica
Pfizer Investigational Site
San Jose, Costa Rica, 00
Pfizer Investigational Site
San Jose, Costa Rica
Croatia
Pfizer Investigational Site
Osijek, Croatia, 31000
Pfizer Investigational Site
Split, Croatia, 21000
Pfizer Investigational Site
Zagreb, Croatia, 10000
Czech Republic
Pfizer Investigational Site
Brno - Zidenice, Czech Republic, 615 00
Pfizer Investigational Site
Brno, Czech Republic, 60200
Pfizer Investigational Site
Brno, Czech Republic, 656 91
Pfizer Investigational Site
Brno, Czech Republic, 65691
Pfizer Investigational Site
Hlucin, Czech Republic, 748 01
Pfizer Investigational Site
Pardubice, Czech Republic, 530 02
Pfizer Investigational Site
Praha 11 - Chodov, Czech Republic, 148 00
Pfizer Investigational Site
Praha 11, Czech Republic, 14800
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Pfizer Investigational Site
Praha 4, Czech Republic, 140 00
Pfizer Investigational Site
Zlin, Czech Republic, 760 01
Denmark
Pfizer Investigational Site
Frederiksberg, Denmark, 2000
Pfizer Investigational Site
Randers NOE, Denmark, 8930
Dominican Republic
Pfizer Investigational Site
Santo Domingo, Dominican Republic, 00000
Finland
Pfizer Investigational Site
Hyvinkaa, Finland, 05800
Germany
Pfizer Investigational Site
Aachen, Germany, 52064
Pfizer Investigational Site
Berlin, Germany, 14059
Pfizer Investigational Site
Frankfurt am Main, Germany, 60590
Pfizer Investigational Site
Halle, Germany, 06108
Pfizer Investigational Site
Halle, Germany, 06128
Pfizer Investigational Site
Herne, Germany, 44652
Pfizer Investigational Site
Ratingen, Germany, 40882
Pfizer Investigational Site
Wuerzburg, Germany, 97080
Korea, Republic of
Pfizer Investigational Site
Daegu, Korea, Republic of, 705-718
Pfizer Investigational Site
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 133-792
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 10700
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44620
Pfizer Investigational Site
Morelia, Michoacan, Mexico, 58249
Pfizer Investigational Site
San Luis Potosi, SLP, Mexico, 78240
Philippines
Pfizer Investigational Site
Lipa City, Batangas, Philippines, 4217
Pfizer Investigational Site
Angeles City, Pampanga, Philippines, 2009
Pfizer Investigational Site
Cebu City, Philippines, 6000
Poland
Pfizer Investigational Site
Bialystok, Poland, 15-337
Pfizer Investigational Site
Cieszyn, Poland, 43-400
Pfizer Investigational Site
Koscian, Poland, 64-000
Pfizer Investigational Site
Krakow, Poland, 31-501
Pfizer Investigational Site
Sopot, Poland, 81-759
Pfizer Investigational Site
Torun, Poland, 87-100
Pfizer Investigational Site
Warszawa, Poland, 02-118
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 82606
Pfizer Investigational Site
Dunajska Streda, Slovakia, 92901
Pfizer Investigational Site
Kosice, Slovakia, 040 01
Pfizer Investigational Site
Nove Zamky, Slovakia, 94001
Pfizer Investigational Site
Povazska Dystrica, Slovakia, 017 01
Pfizer Investigational Site
Zilina, Slovakia, 010 01
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15705
Pfizer Investigational Site
Vigo, Pontevedra, Spain, 36200
Pfizer Investigational Site
A Coruña, Spain, 15006
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Sevilla, Spain, 41009
Pfizer Investigational Site
Valencia, Spain, 46026
Thailand
Pfizer Investigational Site
Rajathevee, Bangkok, Thailand, 10400
Pfizer Investigational Site
Amphoe Muang, Chiang Mai, Thailand, 50200
United Kingdom
Pfizer Investigational Site
Wirral, Merseyside, United Kingdom, CH49 5PE
Pfizer Investigational Site
Cannock, Staffs, United Kingdom, WS11 2XY
Pfizer Investigational Site
Dudley, West Midlands, United Kingdom, DY1 2HQ

Sponsors and Collaborators

Pfizer

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.

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. 2020 Oct 10;:

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.

van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.

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.

Genovese MC, van Vollenhoven RF, Wilkinson B, Wang L, Zwillich SH, Gruben D, Biswas P, Riese R, Takiya L, Jones TV. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016 Jun 23;18:145. doi: 10.1186/s13075-016-1049-3.

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.

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.

van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, Garcia Meijide JA, Wagner S, Forejtova S, Zwillich SH, Gruben D, Koncz T, Wallenstein GV, Krishnaswami S, Bradley JD, Wilkinson B; ORAL Standard Investigators. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):508-19. doi: 10.1056/NEJMoa1112072. Erratum In: N Engl J Med. 2013 Jul 18;369(3):293.

Layout table for additonal information

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00853385
Other Study ID Numbers:	A3921064
First Posted:	March 2, 2009 Key Record Dates
Results First Posted:	January 9, 2013
Last Update Posted:	January 18, 2013
Last Verified:	January 2013

Keywords provided by Pfizer:


oral DMARD JAK inhibitor clinical trial

Additional relevant MeSH terms:

Layout table for MeSH terms

Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Adalimumab	Tofacitinib Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Antirheumatic Agents Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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