Phase 3, Inadequate response to Methotrexate in Rheumatoid Arthritis
Research type
Research Study
Full title
A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate
IRAS ID
58972
Contact name
Peter T Dawes
Contact email
Sponsor organisation
Astrazeneca AB
Eudract number
2010-020743-12
Clinicaltrials.gov Identifier
01197521
Research summary
The study is a 52-week, multi-centre, randomised, double-blind, placebo-controlled (for 24 weeks), parallel group study to investigate the efficacy and safety of fostamatinib disodium (FosD) in patients with active Rheumatoid Arthritis (RA), despite treatment with methotrexate.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 900 patients in total, 300 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 52-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/S0703/53
Date of REC Opinion
26 Oct 2010
REC opinion
Further Information Favourable Opinion