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NCT02114931 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
A Phase 3 study of Arthritis, Rheumatoid, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
- 20
- Study locations
NCT02114931: Completed Phase 3 study of Arthritis, Rheumatoid, sponsored by Amgen.
NCT02114931 is a Phase 3 study of Arthritis, Rheumatoid that has completed, run by Amgen. The registered enrollment target is 467 participants, below the 624-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02114931, a Phase 3 study of Arthritis, Rheumatoid, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).
Primary Outcome
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes. A serious adverse event is defined as an AE that meets at least
Conditions Studied
Interventions
- BIOLOGICAL ABP 501
Study Locations (20)
California
- Research Site - Covina
- Research Site - El Cajon
- Research Site - Hemet
- Research Site - Palm Desert
- Research Site - Van Nuys
- Research Site - Whittier
Florida
- Research Site - Miami
- Research Site - Orlando
- Research Site - Sarasota
Arizona
- Research Site - Peoria
- Research Site - Scottsdale
Maryland
- Research Site - Hagerstown
- Research Site - Wheaton
Alabama
- Research Site - Huntsville
Connecticut
- Research Site - Danbury
Georgia
- Research Site - Sandy Springs
Kentucky
- Research Site - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
What the finished NCT02114931 record still lists
NCT02114931 is an interventional study that assigns participants to a tested intervention. The registered 467 participants enrollment target is mid-sized for trials with a published cap, below the 624-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 1 intervention - of which ABP 501 is the first listed.
NCT02114931 names 20 study sites across 11 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02114931 about?
NCT02114931 is a clinical study titled "Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis". The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).
What is the current status of trial NCT02114931?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2014-04. Estimated completion is 2016-04.
What conditions does trial NCT02114931 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
What interventions are being tested in trial NCT02114931?
The interventions under investigation include: ABP 501 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02114931?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02114931 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02114931's enrollment target sits among peer trials
467 11th of 27 higher than 17 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis, Rheumatoid 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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