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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

Evaluation of long-term safety and effectiveness of fostamatinib in the treatment of rheumatoid arthritis (RA)

Research Site

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

Safety and tolerability will be assessed by adverse event reports, laboratory safety data, vital signs, electrocardiograms and physical examination

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Week 0 (n=1247, 336, 198)

Week 12 (n=1018, 288, 160)

Week 24 (n=800, 230 126)

Week 36 (n=581, 148, 68)

Week 52 (n=290, 28, 14)

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

The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).

Mean DAS28-CRP score

Any AE

Any AE with outcome of death

Any SAE (including events with outcome of death)

Any AE leading to discontinuation of IP

AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event

Percentage of patients who had at least 1 adverse event in any category

Week 0 (n=480, 73, 37)

Week 52 (n=223, 1, 6)

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

Mean mTSS score

Week 0 (n=1271, 342, 201)

Week 12 (n=1061, 298, 166)

Week 24 (n=817, 238, 132)

Week 36 (n=587, 149, 71)

Week 52 (n=296, 28, 14)

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

Mean HAQ-DI score

Overall Study

A total of 5 patients did not receive treatment.

Dave Goldstraw

Measured by radiographic modified total Sharp score (mTSS) and components of mTSS.

Arms	Assigned Interventions
Experimental: A Oral treatment	Drug: Fostamatinib Fostamatinib 100mg twice daily
Experimental: B Oral treatment	Drug: Fostamatinib Fostamatinib 150mg once daily
Experimental: C Oral treatment	Drug: Fostamatinib Fostamatinib 100mg once daily

Evaluation of long-term safety and effectiveness of fostamatinib in the treatment of rheumatoid arthritis (RA) - OSKIRA-X

Official Title

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Verification:

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CSR Synopsis

Trial Results Summaries

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