A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00814307

Recruitment Status : Completed

First Posted : December 24, 2008

Results First Posted : January 11, 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 Phase 3 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 as monotherapy 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 the Phase 2 Rheumatoid Arthritis studies.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	611 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, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis
Study Start Date :	February 2009
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	June 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active 5mg	Drug: CP-690,550 5mg CP-690,550 BID PO for 6 months
Experimental: Active 10 mg	Drug: CP-690,550 10 mg CP-690,550 BID PO for 6 months
Placebo Comparator: Placebo Sequence 1	Drug: Placebo Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
Placebo Comparator: Placebo Sequence 2	Drug: Placebo Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit

Outcome Measures

Primary Outcome Measures :

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 [ Time Frame: Month 3 ]
ACR20 response: greater than or equal to (>=) 20 percent (%) 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 Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 [ Time Frame: Baseline, Month 3 ]
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional 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, 0=least functional difficulty and 3=extreme functional difficulty.
Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 [ Time Frame: Month 3 ]
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (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, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.

Secondary Outcome Measures :

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 [ Time Frame: Week 2, Month 1, 2 ]
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 20% (ACR20) Response at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 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 the HAQ); and CRP.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 [ Time Frame: Week 2, Month 1, 2, 3 ]
ACR50 response: greater than or equal to >=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.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]
ACR50 response: greater than or equal to >=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.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 [ Time Frame: Week 2, Month 1, 2, 3 ]
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.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 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.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and 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) =<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 6 [ Time Frame: Month 6 ]
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (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, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]
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 4, 5 and 6 [ Time Frame: Month 4, 5, 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.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional 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, 0=least functional difficulty and 3=extreme functional difficulty.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional 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, 0=least functional difficulty and 3=extreme functional difficulty.
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Patient Assessment of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]
Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly.
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly.
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]
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 4, 5 and 6 [ Time Frame: Month 4, 5, 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.
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 [ Time Frame: Baseline, Month 3 ]
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.
36-Item Short-Form Health Survey (SF-36) at Month 6 [ Time Frame: Month 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.
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
Participant-rated 12 item questionnaire 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 minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
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.
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 [ Time Frame: Month 6 ]
Participant-rated 12 item questionnaire 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 minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 [ Time Frame: Month 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.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
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.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 [ Time Frame: Month 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.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
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 (EQ-5D)- Health State Profile Utility Score at Month 6 [ Time Frame: Month 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.
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
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.
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 [ Time Frame: Month 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.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of 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 6 [ Time Frame: Month 6 ]
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of 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 and Month 3 [ Time Frame: Baseline, Month 3 ]
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 6 [ Time Frame: Month 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 Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
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.
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 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.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
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.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 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.
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]
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]).
Work Limitations Questionnaire (WLQ) Score at Month 6 [ Time Frame: Month 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]).

Other Outcome Measures:

Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain [ Time Frame: 2 weeks ]
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis [ Time Frame: 2 weeks ]
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly.

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 has active disease at both Screening and Baseline, 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
Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
Patient has washed out of all DMARDs other that antimalarials

Exclusion Criteria:

Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/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

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): NCT00814307

Locations

Show 95 study locations

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United States, Arizona
Pfizer Investigational Site
Gilbert, Arizona, United States, 85234
Pfizer Investigational Site
Tucson, Arizona, United States, 85704
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Sarasota, Florida, United States, 34233
Pfizer Investigational Site
Tampa, Florida, United States, 33614
Pfizer Investigational Site
Venice, Florida, United States, 34292
Pfizer Investigational Site
Zephyr Hills, Florida, United States, 33542
United States, Illinois
Pfizer Investigational Site
Rockford, Illinois, United States, 61107
United States, Maryland
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
United States, Massachusetts
Pfizer Investigational Site
Hyannis, Massachusetts, United States, 02763
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, New Jersey
Pfizer Investigational Site
Teaneck, New Jersey, United States, 07666
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12206
Pfizer Investigational Site
Olean, New York, United States, 14760
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Rocky Mount, North Carolina, United States, 27803
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Pfizer Investigational Site
Minot, North Dakota, United States, 58701
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45408
United States, Pennsylvania
Pfizer Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Pfizer Investigational Site
West Reading, Pennsylvania, United States, 19611-1124
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29601
Pfizer Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
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
Brazil
Pfizer Investigational Site
Goiania, GO, Brazil, 74110-120
Pfizer Investigational Site
Curitiba, PR, Brazil, 80060-240
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 22271-100
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-003
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-903
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04266-010
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 05437-010
Bulgaria
Pfizer Investigational Site
Pleven, Bulgaria, 5800
Pfizer Investigational Site
Plovdiv, Bulgaria, 4000
Pfizer Investigational Site
Plovdiv, Bulgaria, 4002
Pfizer Investigational Site
Sofia, Bulgaria, 1606
Pfizer Investigational Site
Sofia, Bulgaria, 1709
Chile
Pfizer Investigational Site
Santiago, RM, Chile, 7510186
Pfizer Investigational Site
Santiago, RM, Chile, 8360156
Pfizer Investigational Site
Providencia, Santiago, RM, Chile, 7530206
Colombia
Pfizer Investigational Site
Bucaramanga, Santander, Colombia
Pfizer Investigational Site
Barranquilla, Colombia
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 625 00
Pfizer Investigational Site
Ceska Lipa, Czech Republic, 470 01
Pfizer Investigational Site
Hlucin, Czech Republic, 748 01
Pfizer Investigational Site
Pardubice, Czech Republic, 530 02
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Pfizer Investigational Site
Praha 4, Czech Republic, 140 00
Pfizer Investigational Site
Praha 4, Czech Republic, 140 59
Pfizer Investigational Site
Zlin, Czech Republic, 760 01
Dominican Republic
Pfizer Investigational Site
Santo Domingo, Dominican Republic, 00000
Germany
Pfizer Investigational Site
Berlin, Germany, 14059
Pfizer Investigational Site
Halle, Germany, 06108
Pfizer Investigational Site
Hamburg, Germany, 22081
Pfizer Investigational Site
Leipzig, Germany, 04103
Pfizer Investigational Site
Muenchen, Germany, 80336
Pfizer Investigational Site
Nuernberg, Germany, 90429
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 004
Pfizer Investigational Site
Secunderabad, Andra Pradesh, India, 500 003
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 001
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 034
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 079
Pfizer Investigational Site
Mangalore, Karnataka, India, 575 001
Pfizer Investigational Site
Mangalore, Karnataka, India, 575002
Pfizer Investigational Site
Pune, Maharashtra, India, 411 001
Malaysia
Pfizer Investigational Site
Kota Kinabalu, Sabah, Malaysia, 88586
Pfizer Investigational Site
Kuching, Sarawak, Malaysia, 93586
Pfizer Investigational Site
Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46150
Pfizer Investigational Site
Putrajaya, Wilayah Persekutuan, Malaysia, 62250
Mexico
Pfizer Investigational Site
Tijuana, Baja California, Mexico, 22010
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44620
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64020
Pfizer Investigational Site
Chihuahua, Mexico, 31000
Philippines
Pfizer Investigational Site
Dasmarinas, Cavite, Philippines, 4114
Pfizer Investigational Site
Bajada, Davao City, Phlippines, Philippines, 8000
Pfizer Investigational Site
Las Piñas City, Philippines, 1742
Pfizer Investigational Site
Manila, Philippines, 1008
Poland
Pfizer Investigational Site
Warszawa, Poland, 02-256
Pfizer Investigational Site
Wroclaw, Poland, 50-088
Puerto Rico
Pfizer Investigational Site
San Juan, Puerto Rico, 00918
Russian Federation
Pfizer Investigational Site
Petrozavodsk, Russian Federation, 185019
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Ukraine
Pfizer Investigational Site
Kharkiv, Ukraine, 61178
Pfizer Investigational Site
Kyiv, Ukraine, 04114
Pfizer Investigational Site
Lviv, Ukraine, 79011
Pfizer Investigational Site
Simferopol, Crimea, Ukraine, 95017
Pfizer Investigational Site
Vinnitsa, Ukraine, 21018

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.

Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

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.

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

Strand V, Kremer J, Wallenstein G, Kanik KS, Connell C, Gruben D, Zwillich SH, Fleischmann R. Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs. Arthritis Res Ther. 2015 Nov 4;17:307. doi: 10.1186/s13075-015-0825-9.

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.

Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS; ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):495-507. doi: 10.1056/NEJMoa1109071.

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Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00814307
Other Study ID Numbers:	A3921045
First Posted:	December 24, 2008 Key Record Dates
Results First Posted:	January 11, 2013
Last Update Posted:	January 18, 2013
Last Verified:	January 2013

Keywords provided by Pfizer:


Antirheumatic Agents Clinical Trial

Additional relevant MeSH terms:

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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases	Immune System Diseases Tofacitinib Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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