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Dilmapimod in Rheumatoid Arthritis
NCT00320450Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2005
- Primary completion
- Oct 2006
- Countries
- 9
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- dilmapimod
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial in rheumatoid arthritis (RA) comparing SB-681323 with Placebo (2 arms). Primary endpoint: Serum C-reactive Protein at 28 days. Started Nov 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
SB-681323
SB-681323 7.5mg daily + Standard of Care
Placebo
Placebo + Standard of Care
03
Who it enrols
Adult patients with rheumatoid arthritis on stable DMARDs or methotrexate, excluding those with prior non-response to biologicals, active infections, or liver disease.
04
Endpoints
Primary
Serum C-reactive Protein
Secondary
Clinical Symptoms
Safety and Tolerability
Biomarkers
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