At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 119 enrolled
Drug / intervention
abatacept +1 moredrug
Likely dose
abatacept 125 mg/kgfrom 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, Stratified, Open-Label Study to Evaluate the Immunogenicity, Steady State Trough Level, and Safety of Subcutaneous Abatacept (BMS-188667) in Subjects With Rheumatoid Arthritis Administered With or Without Background Methotrexate
In Brief
A Phase 3 clinical trial evaluating abatacept and Methotrexate (MTX) for Rheumatoid Arthritis (RA). Completed, enrolled 119 participants across 22 sites in 4 countries.
Detailed Summary
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis (RA)
CountriesAustralia, Mexico, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartDec 2007
Primary CompletionDec 2008
Study CompletionFeb 2014
TodayJul 2026
First PostedOct 22, 2007
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2008
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.7 years ago
Interventions
abataceptdrug
solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open
Methotrexate (MTX)drug
Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks