drugset / Trial / NCT02092961

Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study

NCT02092961

Phase 2 Terminated 198 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Fostamatinib Small molecule 100 mg Oral

Indications