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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:January 2011
End Date:January 2015
Contact:AstraZeneca Clinical Study Information
Email:information.center@astrazeneca.com
Phone:800-236-9933

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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


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


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
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