Belimumab in Remission of VASculitis

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

Outcome

Missed primary endpoint

paper Compared with placebo, treatment with belimumab did not reduce the risk of a PSE PMID 30666823 ↗

registry p = 0.884; Hazard Ratio (HR) 1.07 (95% CI 0.44 to 2.59) NCT01663623 ↗

Publications

Jayne D, Blockmans D, Luqmani R, Moiseev S, Ji B, Green Y, Hall L, Roth D, Henderson RB, Merkel PA; BREVAS Study Collaborators. Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study. Arthritis Rheumatol. 2019 Jun;71(6):952-963. doi: 10.1002/art.40802. Epub 2019 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belimumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Azathioprine	Small molecule	2 mg/kg	Oral