Status:
COMPLETED
Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00252668
Start Date
June 1 2004
End Date
September 1 2005
Last Update
May 18 2011
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