Phase 3, Inadequate Response to DMARDs 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 DMARDs
IRAS ID
58974
Contact name
Peter T Dawes
Contact email
Sponsor organisation
Astrazeneca AB
Eudract number
2010-020744-35
Clinicaltrials.gov Identifier
01197534
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 FosD in patients with active RA, despite treatment with DMARD therapy.patients will be randomised to receive 1 of the 2 dosing regimens of FosD or a matching placebo regimen in combination with their regular DMARD therapy.Acceptable Dmarks are methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.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.A subset of approximately 200 patients will take part in additional assessments of blood Pressure (BP), pulse rate, electrocardiogram (ECG) and R406 plasma concentrations at Weeks 0, 4 and 8.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/S0703/54
Date of REC Opinion
26 Oct 2010
REC opinion
Further Information Favourable Opinion