A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis (OSKIRA-Asia-1X)

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Fostamatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01640054

D4300C00029

Details and patient eligibility

About

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

Full description

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

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Dosing regimen

Experimental group

Description:

Open label Oral treatment 100mg once daily

Treatment:

Drug: Fostamatinib