Evaluation of safety and effectiveness of fostamatinib compared to placebo in patients in Asia with rheumatoid arthritis - OSKIRA-Asia-1
Study identifier:D4300C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy
Medical condition
Rheumatoid Arthritis
Phase
Phase 2
Healthy volunteers
No
Study drug
Fostamatinib, Placebo
Sex
All
Actual Enrollment
299
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Jun 2013
Study Completion Date: 01 Jul 2013
Study design
Allocation: 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
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dosing A regimen Oral treatment | Drug: Fostamatinib Fostamatinib 100mg twice daily for 12 weeks |
| Experimental: Dosing B regimen Oral treatment | Drug: Fostamatinib Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12 |
| Experimental: Dosing C regimen Oral treatment | Drug: Fostamatinib Fostamatinib 75mg twice daily for 12 weeks |
| Experimental: Dosign D regimen Oral treatment | Drug: Fostamatinib Fostamatinib 50mg twice daily for 12 weeks |
| Placebo Comparator: Dosing E regimen Oral treatment | Drug: Placebo Placebo twice daily for 12 weeks |
Contacts
Investigators
Principal Investigator
Neil - Mackillop
AstraZeneca
