At a glance
ClinicalIndex Comparison RecordPhase 3Active· 338 enrolled
Drug / intervention
Abatacept +2 moredrug
Likely dose
Abatacept 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Abatacept, Adalimumab, and 1 other intervention for Rheumatoid Arthritis. Active but no longer recruiting, targeting 338 participants across 75 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
202220232024202520262027
First PostedJun 2021
Enrollment StartSep 2021
Primary CompletionJun 2023
TodayJul 2026
Study CompletionSep 2027
First PostedJun 2, 2021
Enrollment StartSep 15, 2021
Primary CompletionJun 14, 2023
Study CompletionSep 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.1 years ago
Interventions
Abataceptdrug
Abatacept SC (125 mg) once weekly
Adalimumabdrug
Adalimumab SC (40 mg) once every 2 weeks
Methotrexatedrug
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)