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NCT02373813 · ClinicalTrials.gov registry record · Phase 3
Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
A Phase 3 study of Rheumatoid Arthritis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 371
- Enrollment target
- 20
- Study locations
NCT02373813 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Amgen. The registered enrollment target is 371 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT02373813, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 371 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG etanercept pre-filled syringe subcutaneous injection
- DRUG Oral methotrexate
- DRUG Placebo for etanercept subcutaneous injection
- DRUG Placebo for methotrexate
- DIETARY_SUPPLEMENT Folic acid (non-investigational product)
Study Locations (20)
California
- Research Site - Escondido
- Research Site - Fontana
- Research Site - Hemet
- Research Site - Huntington Beach
- Research Site - La Jolla
- Research Site - Murrieta
- Research Site - Orange
- Research Site - Sacramento
- Research Site - Santa Maria
- Research Site - Torrance
- Research Site - Tustin
- Research Site - Victorville
- Research Site - West Hills
Arizona
- Research Site - Glendale
- Research Site - Mesa
- Research Site - Phoenix
- Research Site - Scottsdale
Alabama
- Research Site - Birmingham
- Research Site - Birmingham
- Research Site - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2015-02-20 |
| Est. Completion | 2019-12-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02373813
The ClinicalTrials.gov registry entry for NCT02373813 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 371 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions - of which etanercept pre-filled syringe subcutaneous injection is the first listed.
NCT02373813 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02373813 about?
NCT02373813 is a clinical study titled "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-blin...
What is the current status of trial NCT02373813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 371 participants. The study started on 2015-02-20. Estimated completion is 2019-12-06.
What conditions does trial NCT02373813 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT02373813?
The interventions under investigation include: etanercept pre-filled syringe subcutaneous injection (DRUG), Oral methotrexate (DRUG), Placebo for etanercept subcutaneous injection (DRUG), Placebo for methotrexate (DRUG), Folic acid (non-investigational product) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02373813?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02373813 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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