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

• Conditions: Patients with active Rheumatoid Arthritis (RA) who have participated in a qualifying study.; MedDRA version: 9.1Level: PTClassification code 10039073

• Registration Number: EUCTR2010-020892-22-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-22
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

For inclusion in the study patients must fulfil the following criteria. 1. Provision of informed consent, prior to any study-specific procedures. 2. Patients who have successfully completed a qualifying study (ie, Studies D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with FosD. Or 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) or Week 6 (D4300C00004).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients must not enter the study if any of the following exclusion criteria are fulfilled: 1. Premature withdrawal from the qualifying study. 2. Development of any of the withdrawal criteria from the qualifying study, including: ? Any physical symptoms of hepatotoxicity. ? Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or bilirubin rise to a value =5 x upper limit of normal (ULN) at any time. ? AST or ALT rises to a value >3 x ULN accompanied by an elevation of total bilirubin >2 x ULN. ? ALT or AST rises to >3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash or eosinophilia. ? Persistent uncontrolled hypertension despite treatment/dose adjustment (as defined in Appendix F). ? Persistent or recurrent gastrointestinal (GI) intolerance or dizziness despite dose reduction. ? Significant infection. ? Cancer: any malignant lesion. 3. Females who are pregnant or lactating. 4. Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified