At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 869 enrolled
Drug / intervention
Abatacept +1 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 Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Abatacept and Adalimumab for Rheumatoid Arthritis. Completed, enrolled 869 participants across 83 sites in 5 countries.
Detailed Summary
The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Canada, Chile, Peru, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartOct 2009
Primary CompletionOct 2011
Study CompletionNov 2012
TodayJul 2026
First PostedJun 30, 2009
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2011
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.0 years ago
Interventions
Abataceptdrug
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Adalimumabdrug
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)