Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Human Genome Sciences Inc., a GSK Company
With
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
