Evaluation of effectiveness of two dosing regimens of fostamatinib compared to placebo in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not responding. - OSKIRA - 2

Study identifier:D4300C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-020744-35

CTIS identifier:N/A

Study Complete

Official Title

(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs

Medical condition

Rheumatoid Arthritis

Phase

Phase 3

Healthy volunteers

No

Study drug

fostamatinib, placebo, fostamatinib

Sex

All

Actual Enrollment

1632

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 Mar 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