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AMPLIFIED: Abatacept vs Adalimumab in Early SE+ RA
NCT04909801Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2021
- Primary completion
- Jun 2023
- Countries
- 14
- Sponsor
- Bristol Myers Squibb
- Modality
- Fc-Fusion Proteins
- Drugs
- abatacept
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, randomised, single-blind trial of abatacept in rheumatoid arthritis (RA) (2 arms), sponsored by Bristol Myers Squibb. Primary endpoint: ACR50 Response at 24 weeks. Started Sep 2021; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Abatacept Arm
Abatacept SC weekly + Methotrexate
Adalimumab Arm
Adalimumab SC every 2 weeks + Methotrexate (Switches to Abatacept at Week 24)
03
Who it enrols
Adults with early (<= 12 months) rheumatoid arthritis who are seropositive (Anti-CCP-2 > 3x ULN and RF+), possess the Shared Epitope HLA Class II risk alleles, and have had an inadequate response to Methotrexate.
04
Endpoints
Primary
ACR50 Response
Secondary
Disease Activity Score 28-CRP Remission
ACR20 Response
ACR50 Response Over Time
ACR70 Response
Clinical Disease Activity Index Remission
Simple Disease Activity Index Remission
Pain Visual Analog Scale
36-item Short Form Survey
05
Results
Not all primary endpoints met
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