Long Term Extension of FosD in Rheumatoid Arthritis
Research type
Research Study
Full title
A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis
IRAS ID
58975
Contact name
Peter T Dawes
Contact email
Sponsor organisation
Astrazeneca AB
Eudract number
2010-020892-22
Clinicaltrials.gov Identifier
Research summary
The study is a multi-centre, parallel group, extension study to assess the long-term safety and efficacy of FosD in patients with active RA who have participated in a qualifying study.It is expected that approximately 2000 patients will be enrolled into this study. Eligible patients are defined as either:-patients who successfully completed the scheduled treatment period of a qualifying study, or-patientsdesignated non-responders at a pre-defined point in 1 of the qualifying studies.The qualifying studies are currently D4300C00001, D4300C00002, D4300C00003 and D4300C00004 (also known as OSKIRA-1, -2, -3 and -4). OSKIRA 4 is not applicable in the UK.-patients receiving 100 mg bid, 150 mg qd or 100 mg qd in their qualifying study will continue on that dose in the extension study. -patients who have had a dose reduction to 100 mg qd in their qualifying study will continue on this reduced dose in the extension study. -patients who are receiving placebo in their qualifying study will be allocated to 100 mg bid in the extension study.The exception to this is patients who had a -dose reduction- whilst receiving placebo.In order to maintain the treatment blind, these patients will receive the reduced active dose of 100 mg qd.The intention is for eligible patients to enter this study directly from the qualifying study, without dose interruption. This extension study (also known as OSKIRA-X) is planned to complete by the end of 2014 (ie, duration of 4 years). The study may be extended in the future (subject to regulatory and ethics committee approvals at the time) to support longer-term safety evaluation if considered necessary or to allow ongoing treatment of patients who continue to benefit. Alternatively, the study may be terminated sooner if development of FosD is discontinued in this indication.
REC name
West of Scotland REC 1
REC reference
10/S0703/56
Date of REC Opinion
26 Oct 2010
REC opinion
Further Information Favourable Opinion