EU Clinical Trial Information System (CTIS)

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

Open label Oral treatment 100mg once daily

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

A long term study to assess the safety of fostamatinib in patients in Asia with Rheumatoid Arthritis

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

Research Site

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

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Insufficient efficacy data was available for analysis due to sparse data collection and the early termination of the study.

ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily

Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Components of ACR response criteria 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

DAS28-CRP score over time

HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily

HAQ-DI score over time

n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey

SF-36 score over time

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, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event

The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.

A long term study to assess the safety of fostamatinib in patients in Asia with Rheumatoid Arthritis - OSKIRA-Asia-1X

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Healthy volunteers

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Documents available

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