Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
Completed · Phase 3 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT02373813
- Run by
- Amgen
- People needed
- 371
- Starts
- 2015-02-20
- Expected to finish
- 2019-12-06
- Last updated by the study team
- 2023-01-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Birmingham, Alabama, United States
- Research Site — Huntsville, Alabama, United States
- Research Site — Glendale, Arizona, United States
- Research Site — Mesa, Arizona, United States
- Research Site — Phoenix, Arizona, United States
- Research Site — Scottsdale, Arizona, United States
- Research Site — Escondido, California, United States
- Research Site — Fontana, California, United States
- Research Site — Hemet, California, United States
- Research Site — Huntington Beach, California, United States
- Research Site — La Jolla, California, United States
- Research Site — Murrieta, California, United States
- Research Site — Orange, California, United States
- Research Site — Sacramento, California, United States
- Research Site — Santa Maria, California, United States
- Research Site — Torrance, California, United States
- Research Site — Tustin, California, United States
- Research Site — Victorville, California, United States
- Research Site — West Hills, California, United States
- Research Site — Doral, Florida, United States
- Research Site — Fort Lauderdale, Florida, United States
- Research Site — Gainesville, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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