Trials / Completed
CompletedNCT02373813
Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 371 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | etanercept pre-filled syringe subcutaneous injection | etanercept for injection in pre-filled syringes |
| DRUG | Oral methotrexate | During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets. During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules. |
| DRUG | Placebo for etanercept subcutaneous injection | etanercept placebo for injection in pre-filled syringes |
| DRUG | Placebo for methotrexate | methotrexate placebo capsules |
| DIETARY_SUPPLEMENT | Folic acid (non-investigational product) | Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care. |
Timeline
- Start date
- 2015-02-20
- Primary completion
- 2019-12-06
- Completion
- 2019-12-06
- First posted
- 2015-02-27
- Last updated
- 2023-01-11
- Results posted
- 2020-12-19
Locations
136 sites across 15 countries: United States, Argentina, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, South Africa, Spain
Source: ClinicalTrials.gov record NCT02373813. Inclusion in this directory is not an endorsement.