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AstraZeneca Announces Top-Line Results of OSKIRA-4 Phase IIb Study of Fostamatinib as a Monotherapy for Rheumatoid Arthritis
Date:12/13/2012

rtin Mackay, President of AstraZeneca Research and Development said: "This Phase IIb dose finding study was designed to evaluate the effect of fostamatinib independent of methotrexate and to inform the further development of fostamatinib as a monotherapy treatment for RA.  A more comprehensive assessment of the benefit/risk profile of fostamatinib used in combination with a DMARD is being undertaken in the pivotal studies that form the OSKIRA Phase III programme which are on track to report in the first half of 2013, and would form the basis of regulatory submissions."

Regulatory filings in the US and EU for use in combination with a DMARD based on the OSKIRA Phase III programme, are expected in the second half of 2013.

A more detailed analysis of the OSKIRA-4 findings will be published in due course.

About the OSKIRA programme
Ongoing Phase III trials in the OSKIRA (Oral Syk Inhibition in Rheumatoid Arthritis) programme, include three pivotal studies assessing the efficacy and safety of fostamatinib; two 12-month studies examining the effect of fostamatinib on patients responding inadequately to DMARDs including methotrexate (OSKIRA-1, OSKIRA-2); a six-month study assessing the effect of fostamatinib on patients who have previously responded inadequately to an anti-TNF therapy (OSKIRA-3); and a long-term extension study looking at the ongoing safety and tolerability of fostamatinib (OSKIRA-X).  The three pivotal studies have as their primary endpoint the proportion of patients with ACR20 compared to placebo (ACR20 = American College of Rheumatology 20% response criteria).  The OSKIRA-1 study also has a co-primary endpoint of change from baseline to week 24 in modified total Sharp score (mTSS), an x-ray endpoint assessing structural progression.

These Phase III studies are expected to be completed in the first half of 2013.

For more information about OSKIRA-4 visit:

SOURCE Rigel Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
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