Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study
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.
Timeline
- Start
- 2011-02
- Primary completion
- 2013-07
- Completion
- 2013-07
Outcome
Met primary endpoint
Stopped: “AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.”
registry analysis (superiority or other test); FOSTA 100 MG PO BID vs PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID; p = 0.022; Treatment difference -1.75 (90% CI -2.75 to -0.42); Van Elteren NCT02092961 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Fostamatinib | Small molecule | 100 mg | Oral |