Belimumab in Remission of VASculitis

Trial ID or NCT#

NCT01663623

Status

recruiting iconRECRUITING

Purpose

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.

Official 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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria. - Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide. - Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment. - Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart. - Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission. Key
Exclusion Criteria:
  1. - Pregnant or nursing. - Receipt of a B cell targeted therapy (other than rituximab) at anytime - Receipt of an investigational biological agent within the past 60 days. - Required management of acute or chronic infections within the past 60 days. - Current drug or alcohol abuse or dependence. - Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. - History of severe allergic reaction to contrast agents or biological medicines.

Investigator(s)

Richard Lafayette
Richard Lafayette
Nephrologist
Professor of Medicine (Nephrology)