Belimumab in Remission of VASculitis
Belimumab in Remission of VASculitis
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.
Key Inclusion Criteria:

 -  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:

 -  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.