Evaluation of efficacy and safety of fostamatinib monotherapy compared with adalimumab monotherapy in patients with rheumatoid arthritis (RA) - OSKIRA -4

Study identifier:D4300C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-023692-26

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis

Medical condition

Rheumatoid Arthritis

Phase

Phase 2

Healthy volunteers

No

Study drug

Fostamatinib and placebo injections, Adalimumab and placebo of fostamatinib, Placebo of fostamatinib, fostamatinib, and placebo injections

Sex

All

Actual Enrollment

644

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Jan 2011
Primary Completion Date: 01 Oct 2012
Study Completion Date: 01 Aug 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria