CompletedPhase 3

A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

United States800 participantsStarted 2009-03

Plain-language summary

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate Exclusion Criteria: * Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

What they're measuring

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

Timeframe: Month 6

Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6

Timeframe: Baseline, Month 6

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

Timeframe: Baseline, Month 3

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

Timeframe: Month 6

Trial details

NCT IDNCT00847613

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-04

Results submitted2012-12-05

View on ClinicalTrials.gov More Arthritis, Rheumatoid trials