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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: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by Amgen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores represe
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 |
What the finished NCT02373813 record still lists
NCT02373813 is an interventional study that assigns participants to a tested intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower).
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 names 20 study sites across 3 states, led by 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.
Learn More About Clinical Trials
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Where NCT02373813's enrollment target sits among peer trials
371 49th of 197 higher than 149 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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