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

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

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Fostamatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing regimen<br>Open label Oral treatment 100mg once daily | Drug: Fostamatinib<br>* Fostamatinib 100mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis