Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Etanercept; Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis.

• Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.

• Active rheumatoid arthritis at the time of screening.

Exclusion Criteria:

• Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.

• Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.

• Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.