NCT04909801

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 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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Abatacept	Abatacept SC (125 mg) once weekly
DRUG	Adalimumab	Adalimumab SC (40 mg) once every 2 weeks
DRUG	Methotrexate	Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-06-14
• Completion: 2027-09-01
• First posted: 2021-06-02
• Last updated: 2025-02-19
• Results posted: 2024-10-15

Locations

75 sites across 14 countries: United States, Argentina, Australia, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study