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Abatacept Low Dose Sub-Study in RA Remission
NCT00989235Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2007
- Primary completion
- Oct 2009
- Sponsor
- Bristol Myers Squibb
- Modality
- Fc-Fusion Proteins
- Drugs
- abatacept
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, randomised, double-blind trial of abatacept in rheumatoid arthritis (RA) (2 arms), sponsored by Bristol Myers Squibb. Primary endpoint: Time to Disease Relapse Through Month 12. Started Apr 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Abatacept 10 mg/kg
Abatacept 10 mg/kg IV monthly + Methotrexate
Abatacept 5 mg/kg
Abatacept 5 mg/kg IV monthly + Methotrexate
03
Who it enrols
Subjects who have completed the main study (IM101023) and have a DAS 28 ESR score of < 2.6 on Day 701.
04
Endpoints
Primary
Time to Disease Relapse Through Month 12
Secondary
Number of Participants Experiencing Disease Relapse
Adjusted Mean Change From Baseline in DAS28 CRP
Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2
Percentage of Participants Who Lost Remission Status
Steady-state Trough Serum Concentration (Cmin) of Abatacept
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations
Participants With Positive Antibody Responses to Abatacept
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