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RC18 in RA with Inadequate Response to TNF-alpha Antagonists
NCT02882087Phase 2
Key facts
- Status
- Terminated
- Start
- Oct 2015
- Primary completion
- Feb 2019
- Countries
- 1
- Sponsor
- RemeGen
- Modality
- Fc-Fusion Proteins
- Drugs
- telitacicept
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial in rheumatoid arthritis (RA) comparing Placebo Comparator with RC18 160 mg (2 arms). Primary endpoint: American College of Rheumatology 20% Response at 24 weeks. Started Oct 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Comparator
Placebo SC weekly + stable MTX
Experimental: RC18 160 mg
RC18 160 mg SC weekly + stable MTX
03
Who it enrols
Adult patients (18-65 years) with moderate to severe rheumatoid arthritis who have had an inadequate response to at least one TNF-alpha antagonist (Infliximab, Adalimumab, or Etanercept) and are on a stable dose of methotrexate.
04
Endpoints
Primary
American College of Rheumatology 20% Response
Secondary
Disease Activity Score 28
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