A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis
- Sponsor
- AstraZeneca
- Study ID
- NCT01640054
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fostamatinib — DRUGFostamatinib 100mg once daily
Study Details
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).
Key Dates
- Start date
- Jul 31, 2012
- Status verified
- Feb 2014
- Primary completion
- Jul 31, 2013
- Completion
- Jul 31, 2013
Study Design
- Enrollment
- 115 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dosing regimenOpen label Oral treatment 100mg once daily
Primary Outcome Measure
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category [ Time Frame: Entry in extension to study termination (variable duration; maximum 52 weeks) ]
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