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NCT04909801 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate
A Phase 3 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 3
- Development phase
- 338
- Enrollment target
- 20
- Study locations
NCT04909801: Active Phase 3 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
NCT04909801 is a Phase 3 study of Rheumatoid Arthritis that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 338 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04909801, a Phase 3 study of Rheumatoid Arthritis, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 338 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.
Primary Outcome
The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medicati
Conditions Studied
Interventions
- DRUG Abatacept
- DRUG Adalimumab
- DRUG Methotrexate
Study Locations (20)
Buenos Aires
- Local Institution - 0012 - CABA
- Local Institution - 0016 - Quilmes
- Local Institution - 0014 - San Isidro
California
- Local Institution - 0036 - Fullerton
- Local Institution - 0086 - Los Alamitos
Maryland
- Local Institution - 0058 - Cumberland
- Local Institution - 0038 - Hagerstown
Other
- Local Institution - 0022 - Buenos Aires
- Local Institution - 0023 - Buenos Aires
Colorado
- Local Institution - 0041 - Aurora
Minnesota
- Local Institution - 0084 - Eagan
New Jersey
- Local Institution - 0040 - Freehold
New York
- NYU Langone Ambulatory Care Brooklyn Heights - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 3 |
What the registry record for NCT04909801 still lists
NCT04909801 is an interventional study that assigns participants to a tested intervention. The registered 338 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 (93% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Abatacept is the first listed.
NCT04909801 names 20 study sites across 15 states, led by Buenos Aires, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04909801 about?
NCT04909801 is a clinical study titled "A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate". The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.
What is the current status of trial NCT04909801?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 338 participants. The study started on 2021-09-15. Estimated completion is 2027-09-01.
What conditions does trial NCT04909801 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT04909801?
The interventions under investigation include: Abatacept (DRUG), Adalimumab (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT04909801?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04909801 being conducted?
This trial has 20 study locations across California, Colorado, Maryland, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04909801's enrollment target sits among peer trials
338 55th of 197 higher than 143 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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