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Evaluation of long-term safety and effectiveness of fostamatinib in the treatment of rheumatoid arthritis (RA) - OSKIRA-X
Study identifier:D4300C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-020892-22
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
Medical condition
Rheumatoid Arthritis
Phase
Phase 3
Healthy volunteers
No
Study drug
Fostamatinib
Sex
All
Actual Enrollment
1917
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Jan 2011
Primary Completion Date: 01 Jun 2013
Study Completion Date: 01 Sept 2013
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Buenos Aires, Argentina
Location
Research Site
Ciudad de Buenos Aires, Argentina
Location
Research Site
Ciudad Autónoma Bs As, Argentina
Location
Research Site
San Miguel de Tucuman, Argentina
Location
Research Site
Rosario, Argentina
Location
Research Site
Ciudad Autonoma Bs As, Argentina
Location
Research Site
San Juan, Argentina
Location
Research Site
Cordoba, Argentina
| Arms | Assigned Interventions |
|---|---|
| Experimental: A Oral treatment | Drug: Fostamatinib Fostamatinib 100mg twice daily |
| Experimental: B Oral treatment | Drug: Fostamatinib Fostamatinib 150mg once daily |
| Experimental: C Oral treatment | Drug: Fostamatinib Fostamatinib 100mg once daily |
Contacts
Investigators
Principal Investigator
Neil Mackillop
AstraZeneca
