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
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
338actual
Sites
75
Countries
Argentina, Australia, Czechia +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-09-15 | actual | When the study began enrolling |
| Primary completion | 2023-06-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-01 | estimated | The whole study's end, after follow-up |
| First posted | 2021-06-02 | actual | When this record first appeared on the registry |
| Results posted | 2024-10-15 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-02-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Rheumatoid Arthritis
Interventions
- Drug: Abatacept — also filed as BMS-188667, Orencia®
- Drug: Adalimumab — also filed as Humira®
- Drug: Methotrexate
Primary outcome
what the primary-completion date above is the date OFPercentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
measured Baseline, week 24
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2021-02-26 · 5.6 MB · Prot_SAP_000.pdf
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