Phase 3, TNF-alpha antagonist in patients with Rheumatoid Arthritis
Research type
Research Study
Full title
A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist
IRAS ID
54008
Contact name
Peter T Dawes
Contact email
Sponsor organisation
Astrazeneca AB
Eudract number
2010-020745-27
Clinicaltrials.gov Identifier
1197755
Research summary
The study is a 24-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy and safety of FosD in patients with active RA, despite treatment with methotrexate, who have had an inadequate response to a single TNF-alpha antagonist. Patients will be randomised to receive 1 of the 2 dosing regimens of FosD or a matching placebo regimen in combination with their regular methotrexate therapy. It is planned to randomise approximately 450 patients in total, 150 to each treatment arm. Patients receiving the placebo will be switched to active treatment at 24 weeks. All treatment allocations will remain double-blind throughout the 24-week treatment period. Patients who successfully complete the scheduled treatment period or those designated non responders at Week 12 will be offered the opportunity to receive FosD therapy in a long term follow-up extension study (OSKIRA-X: Protocol D4300C00005).
REC name
West of Scotland REC 1
REC reference
10/S0703/55
Date of REC Opinion
26 Oct 2010
REC opinion
Further Information Favourable Opinion