Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

Summary

Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA.

Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.

Conditions

• Vasculitis
• Wegener's Granulomatosis
• Microscopic Polyangiitis

Interventions

DRUG

Rituximab plus cyclophosphamide placebo (rituximab group)

375 mg/m\^2 infusions once weekly for 4 week

DRUG

Cyclophosphamide plus rituximab placebo (control group)

2 mg/kg/day orally for months 1-3

DRUG

Azathioprine

2 mg/kg/day orally for months 4-6

DRUG

Methylprednisolone (or other glucocorticoid)

1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab

DRUG

Prednisone

During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• Genentech, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• John H. Stone, MD, MPH · Johns Hopkins University

• Ulrich Specks, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2008-12-31

Completion

2010-01-31

Countries

• United States
• Netherlands

Study Locations