Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 923
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.

Detailed description:
Sub-study:

Full title: Optional Genetic Research

Date: 18 June 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 methotrexate; and/or susceptibility to, progression of and prognosis of RA

Arms:
arm 1: Oral Treatment arm 2: Oral Treatment arm 3: Oral Treatment

Interventions: intervention 1: fostamatinib intervention 2: fostamatinib intervention 3: placebo, fostamatinib
Intervention descriptions: intervention 1: fostamatinib 100 mg twice daily intervention 2: fostamatinib 100 mg twice daily/150 mg once daily intervention 3: Placebo for 24 weeks followed by fostamatinib 100 mg twice daily

Protocol document: