Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,
 combined with rituximab, is effective in treating ANCA-associated vasculitis.
The primary aim of this pilot study is to examine whether an 8 week course of
 glucocorticoids, in combination with rituximab, is effective in inducing and maintaining
 disease remission for up to 6 months in a subset of patients with ANCA-associated vasculitis
 (AAV) who have a more favorable prognosis.

 This pilot study will enroll 20 patients with active AAV. Close patient follow-up will insure
 that any patients who require courses of glucocorticoids longer than two months will receive
 longer therapy, if appropriate for their well-being.
Inclusion Criteria:

 -  Patients ages 18-85 years old

 -  Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus
 Conference

 -  New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's
 granulomatosis (BVAS/WG) of > 3

 Exclusion Criteria:

 -  Renal disease in patients with PR3-ANCA as defined by any of the following:

 -  Urinary red blood cell casts

 -  Biopsy-proven glomerulonephritis

 -  Increase in serum creatinine of >30% over baseline

 -  Severe renal disease in patients with MPO-ANCA as defined by both of the following:

 -  Urinary red blood cell casts or biopsy-proven glomerulonephritis

 -  Estimated glomerular filtration rate < 30 ml/min/1.73m2

 -  Diffuse alveolar hemorrhage requiring ventilatory support

 -  GC treatment for longer than 14 days prior to enrollment unless patient has been on a
 stable maintenance dose of prednisone at the time of the flare

 -  Daily oral cyclophosphamide within 1 month prior to enrollment

 -  Completed a remission induction course of cyclophosphamide or rituximab within 4
 months of enrollment

 -  Hepatitis B infection

 -  HIV infection

 -  History of anti-GBM disease

 -  Other uncontrolled disease, including drug and alcohol abuse, that may interfere with
 the study

 -  Pregnancy or breastfeeding

 -  History of severe allergic reactions to human or chimeric monoclonal antibodies