Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
Phase 4
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00252668
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Subjects who completed the previous double-blind,randomized study.
- Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.
Exclusion Criteria
- Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation.
- Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.
- Secondary Outcome Measures
Name Time Method To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.