At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
Abatacept +1 moredrug
Likely dose
Abatacept 10 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 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study
In Brief
A Phase 3 clinical trial evaluating Abatacept for Rheumatoid Arthritis. Completed, enrolled 108 participants.
Detailed Summary
The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \[DAS 28\]-erythrocyte sedimentation rate \[ESR\] \< 2.6) at Day 701 of study IM101023.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
Primary CompletionOct 2009
First PostedOct 2009
TodayJul 2026
First PostedOct 5, 2009
Enrollment StartApr 1, 2007
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.7 years ago
Interventions
Abataceptdrug
IV solution, IV, 10 mg/Kg, Once monthly, 1 year
Abataceptdrug
IV solution, IV, 5 mg/Kg, Once monthly, 1 year