Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 163
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.

Detailed description:
(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy

Arms:
arm 1: Oral treatment arm 2: Oral treatment arm 3: Oral treatment arm 4: Oral treatment arm 5: Oral treatment

Interventions: intervention 1: Fostamatinib intervention 2: Fostamatinib intervention 3: Fostamatinib intervention 4: Fostamatinib intervention 5: Placebo
Intervention descriptions: intervention 1: Fostamatinib 100mg twice daily for 12 weeks intervention 2: Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12 intervention 3: Fostamatinib 75mg twice daily for 12 weeks intervention 4: Fostamatinib 50mg twice daily for 12 weeks intervention 5: Placebo twice daily for 12 weeks

Protocol document: