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

ClinicalTrials.gov ID: NCT04909801

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Official title

A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04909801
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Bristol-Myers Squibb; Industry
Enrollment: 338 participants

Conditions and interventions

Conditions

Rheumatoid Arthritis

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 15, 2021 (Actual)
Primary completion: Jun 14, 2023 (Actual)
Completion: Sep 1, 2027 (Estimated)
Last update posted: Feb 19, 2025

2021 – 2027

United States locations

U.S. sites: 14
U.S. states: 12
U.S. cities: 14

Facility	City	State	ZIP	Site status
Local Institution - 0036	Fullerton	California	92835	—
Local Institution - 0086	Los Alamitos	California	90720	—
Local Institution - 0041	Aurora	Colorado	80045	—
Local Institution - 0058	Cumberland	Maryland	21502	—
Local Institution - 0038	Hagerstown	Maryland	21740	—
Local Institution - 0084	Eagan	Minnesota	55121	—
Local Institution - 0040	Freehold	New Jersey	07728	—
NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York	11201	—
Local Institution - 0082	Wilmington	North Carolina	28401	—
Local Institution - 0127	Portland	Oregon	97239	—
Local Institution - 0031	Duncansville	Pennsylvania	16635	—
Local Institution - 0034	Jackson	Tennessee	38305	—
Local Institution - 0044	Dallas	Texas	75231	—
Local Institution - 0119	Milwaukee	Wisconsin	53217	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04909801, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 19, 2025 · Synced Nov 13, 2026