Belimumab in Remission of VASculitis

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.