Status:
TERMINATED
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
Lead Sponsor:
AstraZeneca
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
1917 Patients enrolled
Trial Details
Trial ID
NCT01242514
Start Date
January 1 2011
End Date
January 1 2015
Last Update
April 4 2014
Active Locations (308)
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1
Research Site
Anniston, Alabama, United States
2
Research Site
Birmingham, Alabama, United States
3
Research Site
Huntsville, Alabama, United States
4
Research Site
Tuscaloosa, Alabama, United States