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Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP-690,550

Placebo

CP-690,550

Placebo

CP-690,550

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy

Eligibility Criteria

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

Inclusion Criteria:

Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

Exclusion Criteria:

Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

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 joints count (TJC); >= 20% improvement in swollen joints 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 3 analysis.

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 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 Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=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, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1

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 4.5 and 6

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 50% (ACR50) Response at Week 2, Month 1 and 3

ACR50 response: >= 50% improvement in TJC or SJC 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 4.5 and 6

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3

ACR70 response: >=70% improvement in TJC or SJC 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 4.5 and 6

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 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.

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 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, Week 2, Month 1 and 3

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

Patient Assessment of Arthritis Pain at Month 4.5 and 6

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, Week 2, Month 1 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 VAS, where 0 mm = very well and 100 mm = very poorly.

Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6

Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 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 of Arthritis 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, Week 2, Month 1 and 3

SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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).

36-Item Short-Form Health Survey (SF-36) at Month 6

Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3

Participant-rated 12-item questionnaire to 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/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.

Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.

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

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

FACIT-Fatigue Scale (FS):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-FS 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-FS: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-FS 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 - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 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 - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6

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

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

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

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 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 6

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 were reported.

Number of Days as Assessed Using RA-HCRU at Month 6

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, 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 6

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 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 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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). 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 Month 6

Full Information

NCT ID

NCT00960440

First Posted

August 14, 2009

Last Updated

November 29, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00960440

Brief Title

Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

October 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 study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

6. Conditions and Keywords

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

Arthritis, Rheumatoid

Keywords

randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

399 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Title

Sequence 2

Arm Type

Experimental

Arm Title

Sequence 3

Arm Type

Placebo Comparator

Arm Title

Sequence 4

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

double-blind, placebo-controlled phase

Intervention Description

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

double-blind, extension phase

Intervention Description

Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

double-blind, placebo-controlled phase

Intervention Description

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

double-blind, extension phase

Intervention Description

Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Month 3

Title

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

Description

Time Frame

Baseline, Month 3

Title

Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3

Description

Time Frame

Month 3

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1

Description

Time Frame

Week 2, Month 1

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6

Description

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.

Time Frame

Month 4.5, 6

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3

Description

Time Frame

Week 2, Month 1, 3

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6

Description

Time Frame

Month 4.5 and 6

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3

Description

Time Frame

Week 2, Month 1, 3

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6

Description

Time Frame

Month 4.5, 6

Title

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3

Description

Time Frame

Baseline, Week 2, Month 1, 3

Title

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6

Description

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.

Time Frame

Month 4.5, 6

Title

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3

Description

Time Frame

Baseline, Month 3

Title

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6

Description

Time Frame

Month 6

Title

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3

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

Week 2, Month 1, 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 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 4.5, 6

Title

Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3

Description

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

Time Frame

Baseline, Week 2, Month 1, 3

Title

Patient Assessment of Arthritis Pain at Month 4.5 and 6

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 4.5, 6

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3

Description

Time Frame

Baseline, Week 2, Month 1, 3

Title

Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6

Description

Time Frame

Month 4.5, 6

Title

Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 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, 3

Title

Physician Global Assessment of Arthritis 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, Week 2, Month 1 and 3

Description

Time Frame

Baseline, Week 2, Month 1, 3

Title

36-Item Short-Form Health Survey (SF-36) at Month 6

Description

Time Frame

Month 6

Title

Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3

Description

Time Frame

Baseline, Week 2, Month 1, 3

Title

Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6

Description

Time Frame

Month 6

Title

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3

Description

Time Frame

Baseline, Week 2, Month 1, 3

Title

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

Description

Time Frame

Month 6

Title

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

Description

Time Frame

Baseline, Month 3

Title

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6

Description

Time Frame

Month 6

Title

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

Description

Time Frame

Baseline, Month 1, 3

Title

Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6

Description

Time Frame

Month 6

Title

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

Description

Time Frame

Baseline, Month 3

Title

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

Description

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

Time Frame

Baseline, Month 3

Title

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

Description

Time Frame

Month 6

Title

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

Description

Time Frame

Baseline, Month 3

Title

Number of Days as Assessed Using RA-HCRU at Month 6

Description

Time Frame

Month 6

Title

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

Description

Time Frame

Baseline, Month 3

Title

Number of Hours Per Day as Assessed RA-HCRU at Month 6

Description

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 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 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

Time Frame

Baseline, Month 3

Title

Work Limitations Questionnaire (WLQ) Score at Month 6

Description

Time Frame

Month 6

Other Pre-specified Outcome Measures:

Title

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3

Description

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

Time Frame

Week 2, Month 1, 3

Title

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6

Description

Time Frame

Month 4.5, 6

Title

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3

Description

Time Frame

Month 3

Title

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6

Description

Time Frame

Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors. Exclusion Criteria: Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

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

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030-5353

Country

United States

Facility Name

Pfizer Investigational Site

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Pfizer Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

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

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Pfizer Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Pfizer Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

Pfizer Investigational Site

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

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

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Pfizer Investigational Site

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Pfizer Investigational Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Pfizer Investigational Site

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Pfizer Investigational Site

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Facility Name

Pfizer Investigational Site

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015-1153

Country

United States

Facility Name

Pfizer Investigational Site

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Pfizer Investigational Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Pfizer Investigational Site

City

Hixson

State/Province

Tennessee

ZIP/Postal Code

37343

Country

United States

Facility Name

Pfizer Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

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

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

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

Vancouver

State/Province

Washington

ZIP/Postal Code

98664

Country

United States

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98684

Country

United States

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98686

Country

United States

Facility Name

Pfizer Investigational Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Pfizer Investigational Site

City

Daw Park

State/Province

South Australia

ZIP/Postal Code

5041

Country

Australia

Facility Name

Pfizer Investigational Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Pfizer Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Pfizer Investigational Site

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

Pfizer Investigational Site

City

Wien

ZIP/Postal Code

A-1100

Country

Austria

Facility Name

Pfizer Investigational Site

City

Wien

Country

Austria

Facility Name

Pfizer Investigational Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Kortrijk

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Liège

ZIP/Postal Code

4020

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Goiania

State/Province

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Curitiba

State/Province

ZIP/Postal Code

80060-240

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sao Paulo

State/Province

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 2B6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 1S6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Pointe Claire

State/Province

Quebec

ZIP/Postal Code

H9R 3J1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon

Country

France

Facility Name

Pfizer Investigational Site

City

Orleans Cedex 1

ZIP/Postal Code

45032

Country

France

Facility Name

Pfizer Investigational Site

City

Orleans

ZIP/Postal Code

45000

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

Country

France

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

14163

Country

Germany

Facility Name

Pfizer Investigational Site

City

Erlangen

ZIP/Postal Code

91054

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

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Rheine

ZIP/Postal Code

48431

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Pfizer Investigational Site

City

Croom

State/Province

Co. Limerick

Country

Ireland

Facility Name

Pfizer Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Pfizer Investigational Site

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Pfizer Investigational Site

City

Jesi

Country

Italy

Facility Name

Pfizer Investigational Site

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Daegu

ZIP/Postal Code

705-718

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

San Juan

ZIP/Postal Code

00910

Country

Puerto Rico

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

Merida

State/Province

Badajoz

ZIP/Postal Code

06800

Country

Spain

Facility Name

Pfizer Investigational Site

City

Bilbao

State/Province

Bizkaia

ZIP/Postal Code

48013

Country

Spain

Facility Name

Pfizer Investigational Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Pfizer Investigational Site

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Pfizer Investigational Site

City

Niao Sung Hsiang

State/Province

Kaohsiung County

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Kweishan

State/Province

Taoyuan County

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

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

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

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

28941219

Citation

Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

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

27889300

Citation

Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

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

25186034

Citation

Strand V, Burmester GR, Zerbini CA, Mebus CA, Zwillich SH, Gruben D, Wallenstein GV. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken). 2015 Apr;67(4):475-83. doi: 10.1002/acr.22453.

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

23294500

Citation

Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013 Feb 9;381(9865):451-60. doi: 10.1016/S0140-6736(12)61424-X. Epub 2013 Jan 5.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921032&StudyName=Phase%203%2C%20Randomized%2C%20Double-Blind%2C%20Placebo-Controlled%20Study%20Of%20The%20Safety%20And%20Efficacy%20Of%202%20Doses%20Of%20CP-690%2C550%20In%20Patients%20With%20Active%20Rheumatoid%20Arthritis%20On%20Background%20Methotrexate%20With%20Inadequate%20Response%20To%20TNF%20Inhibitors

Description

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Learn more about this trial

Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

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Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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

Learn more about this trial