At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 270 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 Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Abatacept and Placebo for Rheumatoid Arthritis. Completed, enrolled 270 participants across 27 sites in 5 countries.
Detailed Summary
The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Canada, Mexico, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartNov 2007
Primary CompletionDec 2008
Study CompletionFeb 2014
TodayJul 2026
First PostedSep 24, 2007
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2008
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.8 years ago
Interventions
Abataceptdrug
Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term)
Placebodrug
Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)