Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis OSKIRA fostamatinib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 644
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months

Detailed description:
Sub-study:

Full title: Optional Genetic Research

Date: 10 September 2010

Version: 1

Objectives: To collect and store, with appropriate consent , DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or adalimumab; and/or susceptibility to, progression of and prognosis of RA

The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013

Sub-study:

Full title: (Sub-study to 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 Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study

Date: 21 March 2011

Version: 1

Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by:

* Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.

Arms:
arm 1: Oral treatment and subcutaneous injection arm 2: Oral treatment and subcutaneous injection arm 3: Oral treatment and subcutaneous injection arm 4: Oral treatment and subcutaneous injection arm 5: Oral treatment and subcutaneous injection

Interventions: intervention 1: Fostamatinib and placebo injections intervention 2: Fostamatinib and placebo injections intervention 3: Fostamatinib and placebo injections intervention 4: Adalimumab and placebo of fostamatinib intervention 5: Placebo of fostamatinib, fostamatinib, and placebo injections
Intervention descriptions: intervention 1: Fostamatinib 100mg twice daily and placebo injection once every two weeks intervention 2: Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks intervention 3: Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks. intervention 4: Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily. intervention 5: Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).

Protocol document: