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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Genentech, Inc.
• Treatments: Glucocorticoids; Prednisone; Rituximab

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