HGS1006-C1100 Phase 3 - Belimumab for Maintenance of Remission in AAV
Research type
Research Study
Full title
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
IRAS ID
111872
Contact name
David Jayne
Sponsor organisation
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
Eudract number
2011-004569-33
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out if belimumab, when given in combination with azathioprine, is safe and effective in keeping vasculitis disease under control or in remission. The study is open to adults diagnosed with a certain type of vasculitis, called either Wegener??s granulomatosis (WG) or microscopic polyangiitis (MPA). Participants must have recently (in the last 6 months) been treated with certain medicines to control their vasculitis disease symptoms and have achieved remission of their disease. Remission means that the signs and symptoms of the disease are temporarily gone. Treatment with these medicines is sometimes called induction therapy. The drug used in this study is called belimumab. Belimumab is a prescription medicine which is in a group of medicines called monoclonal antibodies. People with autoimmune diseases, including vasculitis, often have high levels of a certain protein (called BLyS) in their blood and this protein helps B cells to live longer. B cells are a type of white blood cell, thought to be involved in the disease. Belimumab binds to and limits the activity of this protein and reduces the number of B cells in the blood. Participants will be randomly placed into 1 of 2 groups. Both groups will be given azathioprine, a drug used to reduce the risk of vasculitis returning. Then 1 group will receive belimumab and the other will receive placebo (placebo looks the same as belimumab but it contains no active medicine). The study will continue for at least 1 year, but could last up to 3 years or longer. If the results are positive, participants may have the opportunity to take part in a 6 month open-label extension, during which time all participants will receive belimumab. Globally, about 300-400 people who have vasculitis (specifically WG or MPA) will take part in this study.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
12/EE/0523
Date of REC Opinion
20 Dec 2012
REC opinion
Favourable Opinion