At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 106 enrolled
Drug / intervention
Placebo +2 morebiological
Likely dose
Belimumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis
In Brief
A Phase 3 clinical trial evaluating Placebo, Belimumab 10 mg/kg, and 1 other intervention for Vasculitis. Completed, enrolled 106 participants across 89 sites in 20 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasculitis
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Mexico, Norway, Peru, Poland, Romania, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
CollaboratorsGlaxoSmithKline
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartMar 2013
Primary CompletionFeb 2017
TodayJul 2026
First PostedAug 13, 2012
Enrollment StartMar 20, 2013
Primary CompletionFeb 6, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.9 years ago
Interventions
Placebobiological
Placebo
Belimumab 10 mg/kgbiological
Belimumab 10 mg/kg
Azathioprinedrug
Azathioprine