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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis

In brief

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.

Key facts

Study ID

NCT00104299

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

197

Starts

2005-01-01

Expected to finish

2010-01-01

Last updated by the study team

2017-04-21

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston University — Boston, Massachusetts, United States
• Mayo Clinic Foundation — Rochester, Minnesota, United States
• Hospital for Special Surgery — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• University Hospital Groningen — Groningen, Netherlands

Full record on ClinicalTrials.gov

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