Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Etanercept; Methotrexate

Criteria

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.