drugset
drugset / Trial / 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

NCT04909801 ↗

Phase 3 Active not recruiting 338 enrolled Bristol-Myers Squibb
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-09-15
Primary completion
2023-06-14
Completion
2027-09-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Abatacept vs Adalimumab, Then Abatacept (OLE Period); p = 0.9026; Adjusted Odds Ratio 1.0 (95% CI 0.6 to 1.6); Regression, Logistic NCT04909801 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 125 mg Subcutaneous
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Background Methotrexate Small molecule 15 mg Oral
Background Methotrexate Small molecule 25 mg Oral

Indications

rheumatoid arthritis