A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Fostamatinib

• Registration Number: NCT01640054
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).

Detailed Description

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-13
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2013-11-21
• Results First Submitted QC: 2013-11-21
• Results First Posted: 2014-01-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Provision of informed consent prior to any study-specific procedures.
• Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.

Exclusion Criteria

• Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient's disease is not adequately controlled on current treatment.
• Development of any of the withdrawal criteria from study D4300C00008
• Females who are pregnant or breast feeding
• Any other clinically significant disease or disorder, which in the opinion of the Investigator might put the patient at risk due to participation in the study, or may influence the results of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dosing regimen	Fostamatinib	Open label Oral treatment 100mg once daily

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category	Entry in extension to study termination (variable duration; maximum 52 weeks)	AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event

Secondary Outcome Measures

Name	Time	Method
DAS28-CRP Score Over Time	Every 12 weeks for one year then every 24 weeks until study end	CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily
SF-36 Score Over Time	Every 12 weeks for one year then yearly until study end	n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey
Components of ACR Response Criteria Over Time	Every 12 weeks for one year then every 24 weeks until study end	ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily
HAQ-DI Score Over Time	Every 12 weeks for one year then every 24 weeks until study end	HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam