Study identifier:D4300C00004Sub
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study
Rheumatoid Arthritis
Phase 2
No
Fostamatinib, Adalimumab, Placebo of Fostamatinib, Placebo of Adalimumab
All
198
Interventional
18 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jul 2014 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dosing Group A Oral treatment and subcutaneous injection. | Drug: Fostamatinib Fostamatinib 100mg twice daily. Drug: Placebo of Adalimumab Placebo injection once every two weeks. |
Active Comparator: Dosing Group D Oral treatment and subcutaneous injection. | Drug: Adalimumab Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks. Drug: Placebo of Fostamatinib Placebo bid for 6 weeks. |
Placebo Comparator: Dosing Group E Placebo bid for 6 weeks followed by switch to 100 mg fostamatinib bid for 24 weeks, plus placebo subcutaneous injection every 2 weeks. | Drug: Fostamatinib Fostamatinib 100mg twice daily. Drug: Placebo of Fostamatinib Placebo bid for 6 weeks. Drug: Placebo of Adalimumab Placebo injection once every two weeks. |