Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis OSKIRA fostamatinib CE-MRI DCE-MRI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 198
Healthy volunteers: no

Brief summary:
This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative and more sensitive modalities for measuring the beneficial effects of syk inhibition with fostamatinib in patients with active RA. This MRI sub-study was reported later than the main study due to recruitment delays at specialist imaging sites and so is registered and presented entirely separately to the main study results.

This study will investigate the impact of treatment on joint activity and damage by assessing synovitis, osteitis, bone erosions and joint space narrowing.

Detailed description:
Sub-study to OSKIRA-4: A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study Date: 21 March 2011 Version: 1 Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by: - Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.

Arms:
arm 1: Oral treatment and subcutaneous injection. arm 2: Oral treatment and subcutaneous injection. arm 3: Placebo bid for 6 weeks followed by switch to 100 mg fostamatinib bid for 24 weeks, plus placebo subcutaneous injection every 2 weeks.

Interventions: intervention 1: Fostamatinib intervention 2: Adalimumab intervention 3: Placebo of Fostamatinib intervention 4: Placebo of Adalimumab
Intervention descriptions: intervention 1: Fostamatinib 100mg twice daily. intervention 2: Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks. intervention 3: Placebo bid for 6 weeks. intervention 4: Placebo injection once every two weeks.

Protocol document: