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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP 690,550

CP-690,550

Placebo

Biologic TNFi

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring oral DMARD, JAK inhibitor, 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 must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L
History of any other autoimmune rheumatic disease other than Sjogren's syndrome
No malignancy or history of malignancy.
History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
Patients who have previously received adalimumab therapy for any reason.
Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

5mg

10 mg

Placebo Sequence 1

Placebo Sequence 2

adalimumab

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6

ACR20 response: greater than or equal to (>=) 20% improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6

DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3

ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12

ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6

DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12

DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Patient Assessment of Arthritis Pain at Month 9 and 12

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12

Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.

36-Item Short-Form Health Survey (SF-36) at Month 9 and 12

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6

FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12

Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.

Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12

Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12

Work Limitations Questionnaire (WLQ) Score at Month 3 and 6

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).

Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6

Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12

RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12

Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

Number of Days as Assessed Using RA-HCRU at Month 12

Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6

RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.

Number of Hours Per Day as Assessed RA-HCRU at Month 12

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12

Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Full Information

NCT ID

NCT00853385

First Posted

February 27, 2009

Last Updated

January 10, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00853385

Brief Title

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

Official Title

Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (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 is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

oral DMARD, JAK inhibitor, clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

717 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5mg

Arm Type

Experimental

Arm Title

10 mg

Arm Type

Experimental

Arm Title

Placebo Sequence 1

Arm Type

Placebo Comparator

Arm Title

Placebo Sequence 2

Arm Type

Placebo Comparator

Arm Title

adalimumab

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

CP 690,550

Intervention Description

tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Biologic TNFi

Other Intervention Name(s)

Humira (Adalimumab)

Intervention Description

placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6

Description

Time Frame

Month 6

Title

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3

Description

Time Frame

Baseline, Month 3

Title

Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6

Description

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3

Description

Time Frame

Month 1, 3

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6

Description

Time Frame

Month 1, 3, 6

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6

Description

Time Frame

Month 1, 3, 6

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

Description

Time Frame

Baseline, Month 1, 3, 6, 9, 12

Title

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

Description

Time Frame

Baseline, Month 1, 3, 6, 9, 12

Title

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6

Description

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

Time Frame

Month 1, 3, 6

Title

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12

Description

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

Time Frame

Month 9, 12

Title

Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6

Description

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Baseline, Month 1, 3, 6

Title

Patient Assessment of Arthritis Pain at Month 9 and 12

Description

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Time Frame

Month 9, 12

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 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

Baseline, Month 1, 3, 6

Title

Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12

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 9, 12

Title

36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

36-Item Short-Form Health Survey (SF-36) at Month 9 and 12

Description

Time Frame

Month 9, 12

Title

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12

Description

Time Frame

Month 12

Title

Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12

Description

Time Frame

Month 12

Title

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12

Description

Time Frame

Month 12

Title

Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6

Description

Time Frame

Baseline, Month 1, 3, 6

Title

Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12

Description

Time Frame

Month 12

Title

Work Limitations Questionnaire (WLQ) Score at Month 3 and 6

Description

Time Frame

Month 3, 6

Title

Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12

Description

Time Frame

Baseline, Month 12

Title

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12

Description

Time Frame

Month 12

Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12

Description

Time Frame

Month 12

Title

Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Number of Days as Assessed Using RA-HCRU at Month 12

Description

Time Frame

Month 12

Title

Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6

Description

Time Frame

Baseline, Month 3, 6

Title

Number of Hours Per Day as Assessed RA-HCRU at Month 12

Description

Time Frame

Month 12

Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6

Description

Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Time Frame

Baseline, Month 3, 6

Title

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12

Description

Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Time Frame

Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria. The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis. The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs. Exclusion Criteria: Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L History of any other autoimmune rheumatic disease other than Sjogren's syndrome No malignancy or history of malignancy. History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event. Patients who have previously received adalimumab therapy for any reason. Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label. Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

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

Glendale

State/Province

Arizona

ZIP/Postal Code

85304

Country

United States

Facility Name

Pfizer Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Pfizer Investigational Site

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

Pfizer Investigational Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Pfizer Investigational Site

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Pfizer Investigational Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Pfizer Investigational Site

City

Largo

State/Province

Florida

ZIP/Postal Code

33777

Country

United States

Facility Name

Pfizer Investigational Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Pfizer Investigational Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33782

Country

United States

Facility Name

Pfizer Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Pfizer Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Pfizer Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

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

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Pfizer Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Pfizer Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Pfizer Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40515

Country

United States

Facility Name

Pfizer Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Pfizer Investigational Site

City

Haverhill

State/Province

Massachusetts

ZIP/Postal Code

01830

Country

United States

Facility Name

Pfizer Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

Facility Name

Pfizer Investigational Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

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

Austin

State/Province

Texas

ZIP/Postal Code

78705

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

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Pfizer Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

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

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Pfizer Investigational Site

City

Cairns

State/Province

Queensland

ZIP/Postal Code

4870

Country

Australia

Facility Name

Pfizer Investigational Site

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Pfizer Investigational Site

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Pfizer Investigational Site

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

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

Sevlievo

ZIP/Postal Code

5400

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

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1L7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Lunenburg

State/Province

Nova Scotia

ZIP/Postal Code

B0J 2C0

Country

Canada

Facility Name

Pfizer Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

ZIP/Postal Code

7510186

Country

Chile

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

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

Rancagua

State/Province

VI Region

ZIP/Postal Code

2841959

Country

Chile

Facility Name

Pfizer Investigational Site

City

Cartago

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

San Jose

ZIP/Postal Code

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

San Jose

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Brno - Zidenice

ZIP/Postal Code

615 00

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Brno

ZIP/Postal Code

60200

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Brno

ZIP/Postal Code

65691

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 11 - Chodov

ZIP/Postal Code

148 00

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha 11

ZIP/Postal Code

14800

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

Zlin

ZIP/Postal Code

760 01

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Frederiksberg

ZIP/Postal Code

2000

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Randers NOE

ZIP/Postal Code

8930

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Santo Domingo

ZIP/Postal Code

00000

Country

Dominican Republic

Facility Name

Pfizer Investigational Site

City

Hyvinkaa

ZIP/Postal Code

05800

Country

Finland

Facility Name

Pfizer Investigational Site

City

Aachen

ZIP/Postal Code

52064

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Pfizer Investigational Site

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Pfizer Investigational Site

City

Halle

ZIP/Postal Code

06108

Country

Germany

Facility Name

Pfizer Investigational Site

City

Halle

ZIP/Postal Code

06128

Country

Germany

Facility Name

Pfizer Investigational Site

City

Herne

ZIP/Postal Code

44652

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ratingen

ZIP/Postal Code

40882

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Pfizer Investigational Site

City

Daegu

ZIP/Postal Code

705-718

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

ZIP/Postal Code

10700

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44620

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58249

Country

Mexico

Facility Name

Pfizer Investigational Site

City

San Luis Potosi

State/Province

SLP

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Angeles City

State/Province

Pampanga

ZIP/Postal Code

2009

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Bialystok

ZIP/Postal Code

15-337

Country

Poland

Facility Name

Pfizer Investigational Site

City

Cieszyn

ZIP/Postal Code

43-400

Country

Poland

Facility Name

Pfizer Investigational Site

City

Koscian

ZIP/Postal Code

64-000

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Pfizer Investigational Site

City

Sopot

ZIP/Postal Code

81-759

Country

Poland

Facility Name

Pfizer Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Dunajska Streda

ZIP/Postal Code

92901

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Nove Zamky

ZIP/Postal Code

94001

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Povazska Dystrica

ZIP/Postal Code

017 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

15705

Country

Spain

Facility Name

Pfizer Investigational Site

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36200

Country

Spain

Facility Name

Pfizer Investigational Site

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Pfizer Investigational Site

City

Rajathevee

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Amphoe Muang

State/Province

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Cannock

State/Province

Staffs

ZIP/Postal Code

WS11 2XY

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Dudley, West Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

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.

Results Reference

derived

PubMed Identifier

35382883

Citation

Bartlett SJ, Bingham CO, van Vollenhoven R, Murray C, Gruben D, Gold DA, Cella D. The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials. Arthritis Res Ther. 2022 Apr 5;24(1):83. doi: 10.1186/s13075-022-02724-x.

Results Reference

derived

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

34636000

Citation

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

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

33059710

Citation

Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.

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

derived

PubMed Identifier

29949132

Citation

Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

Results Reference

derived

PubMed Identifier

29696833

Citation

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

Results Reference

derived

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.

Results Reference

derived

PubMed Identifier

27334658

Citation

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

Results Reference

derived

PubMed Identifier

26275429

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.

Results Reference

derived

PubMed Identifier

25047021

Citation

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.

Results Reference

derived

PubMed Identifier

22873531

Citation

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

Results Reference

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Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921064&StudyName=A%20Phase%203%20Study%20Comparing%202%20Doses%20Of%20CP-690%2C550%20And%20The%20Active%20Comparator%2C%20Humira%20%28adalimumab%29%20Vs.%20Placebo%20For%20Treatment%20Of%20Rh

Description

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

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

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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