drugset / Trial / NCT01663623

Belimumab in Remission of VASculitis

NCT01663623

Phase 3 Completed 106 enrolled GlaxoSmithKline GlaxoSmithKline · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.

Timeline

Start
2013-03-20
Primary completion
2017-02-06
Completion
2017-02-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 10 mg/kg Intravenous
Background Azathioprine Small molecule 2 mg/kg Oral

Indications