Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis

Short-Course Glucocorticoids and Rituximab in 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