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TuNEX (ENIA11) + Methotrexate in Rheumatoid Arthritis
NCT01709760Phase 3
Key facts
- Status
- Unknown
- Start
- Nov 2012
- Primary completion
- Dec 2017
- Countries
- 1
- Sponsor
- Mycenax Biotech Inc.
- Modality
- Fc-Fusion Proteins
- Drugs
- etanercept
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, randomised, double-blind trial of etanercept in rheumatoid arthritis (RA) (2 arms), sponsored by Mycenax Biotech Inc. Primary endpoint: American College of Rheumatology 20% Improvement Criteria at 24 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
methotrexate & ENIA11
ENIA11 25 mg sc twice weekly + Methotrexate
methotrexate & Placebo
Placebo sc twice weekly + Methotrexate
03
Who it enrols
Adult patients with active rheumatoid arthritis despite stable methotrexate therapy, with no history of prior failure on etanercept or other TNF inhibitors.
04
Endpoints
Primary
American College of Rheumatology 20% Improvement Criteria
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