Trial Search Results
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.
Stanford is currently accepting patients for this trial.
Human Genome Sciences Inc., a GSK Company
- Biological: Placebo
- Biological: Belimumab 10 mg/kg
- Drug: Azathioprine
Key Inclusion Criteria:
- Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill
- Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids
and 1 of the following medications: rituximab, oral cyclophosphamide OR IV
- 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
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
- History of severe allergic reaction to contrast agents or biological medicines.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study