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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Genentech, Inc.; Immune Tolerance Network (ITN)
• Treatments: Azathioprine; Cyclophosphamide; Glucocorticoids; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Rituximab

Criteria

Inclusion Criteria:

• Weight of at least 88 pounds(40 kilograms)

• Diagnosis of Wegener's granulomatosis or microscopic polyangiitis according to the definitions of the Chapel Hill Consensus Conference

• Newly diagnosed patient of Wegener's granulomatosis or microscopic polyangiitis OR must be experiencing a disease flare characterized by: (a) active disease with a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 3 or greater that would normally require treatment with CYC; OR (b) disease severe enough to require treatment with CYC; OR (c) must be positive for either PR3-ANCA (ANCA directed against proteinase 3) or MPO-ANCA (ANCA directed against myeloperoxidase)at the screening

• Willing to use acceptable forms of contraception for the duration of the study and for up to 1 year after stopping study medications

• Willing to report pregnancies (female participants or male participants' partners) occurring at any time during the study and for up to 1 year after stopping study medications

• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Diagnosis of Churg-Strauss Syndrome according to the definitions of the Chapel Hill Consensus Conference

• Have limited disease that would not normally be treated with CYC

• Requires mechanical ventilation because of alveolar hemorrhage

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

• Active systemic infection

• Have a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia complicated by pleural cavity or lung abscess, within 6 months prior to study entry

• History of or current hepatitis B or C infection

• HIV (human immunodeficiency virus) infected

• Acute or chronic liver disease that, in the opinion of the investigator, may interfere with the study

• History of or active cancer diagnosed within the last 5 years. Individuals with squamous cell or basal cell carcinomas of the skin and individuals with cervical carcinoma in situ who have received curative surgical treatment may be eligible for this study.

• History of anti-glomerular basement membrane (anti-GBM) disease

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

• Pregnancy or breastfeeding