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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CP-690,550
CP-690,550
Placebo
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Antirheumatic Agents Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Active 5mg

Active 10 mg

Placebo Sequence 1

Placebo Sequence 2

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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]).

Full Information

First Posted
December 22, 2008
Last Updated
January 10, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00814307
Brief Title
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Antirheumatic Agents Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
611 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active 5mg
Arm Type
Experimental
Arm Title
Active 10 mg
Arm Type
Experimental
Arm Title
Placebo Sequence 1
Arm Type
Placebo Comparator
Arm Title
Placebo Sequence 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
5mg CP-690,550 BID PO for 6 months
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
10 mg CP-690,550 BID PO for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
Description
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).
Time Frame
Month 3
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
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
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2
Description
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.
Time Frame
Week 2, Month 1, 2
Title
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6
Description
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.
Time Frame
Month 4, 5, 6
Title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3
Description
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.
Time Frame
Week 2, Month 1, 2, 3
Title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6
Description
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.
Time Frame
Month 4, 5, 6
Title
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
Description
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.
Time Frame
Week 2, Month 1, 2, 3
Title
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6
Description
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.
Time Frame
Month 4, 5, 6
Title
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
Description
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.
Time Frame
Month 6
Title
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
Description
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.
Time Frame
Baseline, Week 2, Month 1, 2, 3
Title
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6
Description
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.
Time Frame
Month 4, 5, 6
Title
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
Description
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.
Time Frame
Baseline, Week 2, Month 1, 2, 3
Title
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6
Description
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.
Time Frame
Month 4, 5, 6
Title
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Description
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 Frame
Baseline, Week 2, Month 1, 2, 3
Title
Patient Assessment of Arthritis Pain at Month 4, 5 and 6
Description
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.
Time Frame
Month 4, 5, 6
Title
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Description
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.
Time Frame
Baseline, Week 2, Month 1, 2, 3
Title
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6
Description
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.
Time Frame
Month 4, 5, 6
Title
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Description
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame
Baseline, Week 2, Month 1, 2, 3
Title
Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6
Description
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame
Month 4, 5, 6
Title
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
36-Item Short-Form Health Survey (SF-36) at Month 6
Description
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.
Time Frame
Month 6
Title
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Description
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.
Time Frame
Month 6
Title
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Description
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.
Time Frame
Month 6
Title
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
Description
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.
Time Frame
Month 6
Title
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6
Description
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.
Time Frame
Month 6
Title
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Description
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.
Time Frame
Month 6
Title
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Description
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.
Time Frame
Month 6
Title
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Number of Days as Assessed Using RA-HCRU at Month 6
Description
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.
Time Frame
Month 6
Title
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
Description
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.
Time Frame
Month 6
Title
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
Description
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.
Time Frame
Month 6
Title
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Description
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]).
Time Frame
Baseline, Month 3
Title
Work Limitations Questionnaire (WLQ) Score at Month 6
Description
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]).
Time Frame
Month 6
Other Pre-specified Outcome Measures:
Title
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Description
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 Frame
2 weeks
Title
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Pfizer Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Pfizer Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Pfizer Investigational Site
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Pfizer Investigational Site
City
Zephyr Hills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Pfizer Investigational Site
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Pfizer Investigational Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Pfizer Investigational Site
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02763
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Pfizer Investigational Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Pfizer Investigational Site
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pfizer Investigational Site
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27803
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611-1124
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Pfizer Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pfizer Investigational Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Pfizer Investigational Site
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Pfizer Investigational Site
City
Goiania
State/Province
GO
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-240
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05437-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
ZIP/Postal Code
8360156
Country
Chile
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago, RM
ZIP/Postal Code
7530206
Country
Chile
Facility Name
Pfizer Investigational Site
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Barranquilla
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Ceska Lipa
ZIP/Postal Code
470 01
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Hlucin
ZIP/Postal Code
748 01
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Santo Domingo
ZIP/Postal Code
00000
Country
Dominican Republic
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Pfizer Investigational Site
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Nuernberg
ZIP/Postal Code
90429
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 004
Country
India
Facility Name
Pfizer Investigational Site
City
Secunderabad
State/Province
Andra Pradesh
ZIP/Postal Code
500 003
Country
India
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 015
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 001
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 079
Country
India
Facility Name
Pfizer Investigational Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575 001
Country
India
Facility Name
Pfizer Investigational Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Pfizer Investigational Site
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88586
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Petaling Jaya
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
46150
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Putrajaya
State/Province
Wilayah Persekutuan
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Dasmarinas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Bajada, Davao City
State/Province
Phlippines
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Las Piñas City
ZIP/Postal Code
1742
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Pfizer Investigational Site
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61178
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Simferopol, Crimea
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
35577477
Citation
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.
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PubMed Identifier
34921355
Citation
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.
Results Reference
derived
PubMed Identifier
34870800
Citation
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.
Results Reference
derived
PubMed Identifier
33127856
Citation
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.
Results Reference
derived
PubMed Identifier
32816215
Citation
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;:
Results Reference
derived
PubMed Identifier
30177460
Citation
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.
Results Reference
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PubMed Identifier
28143815
Citation
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.
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PubMed Identifier
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Citation
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.
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Citation
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.
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Citation
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Citation
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Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921045&StudyName=A%20Phase%203%20study%20comparing%202%20doses%20of%20CP-690%2C550%20vs.%20placebo%20for%20treatment%20of%20rheumatoid%20arthritis
Description
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Learn more about this trial

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

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