Trials / Completed
CompletedNCT01663623
Belimumab in Remission of VASculitis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Human Genome Sciences Inc., a GSK Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | Placebo |
| BIOLOGICAL | Belimumab 10 mg/kg | Belimumab 10 mg/kg |
| DRUG | Azathioprine | Azathioprine |
Timeline
- Start date
- 2013-03-20
- Primary completion
- 2017-02-06
- Completion
- 2017-02-06
- First posted
- 2012-08-13
- Last updated
- 2018-04-17
- Results posted
- 2018-04-17
Locations
89 sites across 20 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Mexico, Norway, Peru, Poland, Romania, Russia, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01663623. Inclusion in this directory is not an endorsement.