drugset / Trial / NCT01264770

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

NCT01264770

Phase 2 Terminated 644 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2011-01
Primary completion
2012-10
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Fostamatinib Small molecule 100 mg Oral
Subject Fostamatinib Small molecule 150 mg Oral

Indications