Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

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 with rheumatoid arthritis (RA).

Official Title
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(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Fostamatinib
* Drug: Fostamatinib
* Drug: Fostamatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003). Exclusion Criteria: Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004) Females who are pregnant or breast feeding Poorly controlled hypertension Significant liver function test abnormalities or physical symptoms of hepatotoxicity Significant infection Gastrointestinal intolerance Cancer

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Oral treatment | Drug: Fostamatinib<br>* Fostamatinib 100mg twice daily<br>|
| Experimental: B<br>Oral treatment | Drug: Fostamatinib<br>* Fostamatinib 150mg once daily<br>|
| Experimental: C<br>Oral treatment | 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, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event | Entry in extension to end of study (variable duration; maximum 109 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean DAS28-CRP Score | DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily | Weeks 0, 12, 24, 36 and 52 | 
| Mean mTSS Score | mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily | Weeks 0 and 52 | 
| Mean HAQ-DI Score | HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily | Weeks 0, 12, 24, 36 and 52 | 

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