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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jun 19, 2014

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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