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Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy. This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.
Details
| Lead sponsor | Amgen |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 371 |
| Start date | Fri Feb 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Dec 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Rheumatoid Arthritis
Interventions
- etanercept pre-filled syringe subcutaneous injection
- Oral methotrexate
- Placebo for etanercept subcutaneous injection
- Placebo for methotrexate
- Folic acid (non-investigational product)
Countries
France, Italy, South Africa, Greece, Germany, Hungary, Mexico, Poland, Argentina, Canada, Bulgaria, Portugal, United States, Spain, Czechia