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PF-06410293 (Abrilada) vs Adalimumab in RA
NCT02480153Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2015
- Primary completion
- Aug 2016
- Countries
- 24
- Sponsor
- Pfizer
- Modality
- Monoclonal Antibodies
- Drugs
- adalimumab
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, randomised, double-blind trial of adalimumab in rheumatoid arthritis (RA) (2 arms), sponsored by Pfizer. Primary endpoint: American College of Rheumatology 20% Response at 12 weeks. Started Jun 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PF-06410293
PF-06410293 40 mg SC every other week + Methotrexate
Adalimumab
Adalimumab 40 mg SC every other week + Methotrexate
03
Who it enrols
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients must have at least 6 tender and 6 swollen joints and elevated Hs-CRP. Exclusion criteria include active TB, severe heart failure, or recent serious infection.
04
Endpoints
Primary
American College of Rheumatology 20% Response
Secondary
American College of Rheumatology 20% Response
American College of Rheumatology 50% Response
American College of Rheumatology 70% Response
Disease Activity Score 28-joint count C-reactive protein
Health Assessment Questionnaire-Disability Index
Anti-drug Antibodies
Neutralizing Antibodies
Treatment Emergent Adverse Events
05
Results
Primary endpoints met
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