Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

Phase 2 Terminated 644 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months

Timeline

Start: 2011-01
Primary completion: 2012-10
Completion: 2013-08

Outcome

Mixed primary results

Stopped: “AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.”

paper Fostamatinib demonstrated a significant improvement in DAS-28(CRP) score from baseline versus placebo at Week 6 for arms A and B, but not C. PMID 25074688 ↗

paper Fostamatinib was significantly less effective than adalimumab at Week 24 based on DAS-28(CRP). PMID 25074688 ↗

release “In the OSKIRA-4 study, fostamatinib as a monotherapy met the first primary objective” astrazeneca.com ↗

release “The OSKIRA-4 study did not meet its second primary objective” astrazeneca.com ↗

Publications

Taylor PC, Genovese MC, Greenwood M, Ho M, Nasonov E, Oemar B, Stoilov R, Vencovsky J, Weinblatt M. OSKIRA-4: a phase IIb randomised, placebo-controlled study of the efficacy and safety of fostamatinib monotherapy. Ann Rheum Dis. 2015 Dec;74(12):2123-9. doi: 10.1136/annrheumdis-2014-205361. Epub 2014 Jul 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Fostamatinib	Small molecule	100 mg	Oral
Subject	Fostamatinib	Small molecule	150 mg	Oral