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| Sponsor: | Fernando Fervenza |
|---|---|
| Collaborators: |
Genentech Biogen Idec National Center for Research Resources (NCRR) |
| Information provided by (Responsible Party): | Fernando Fervenza, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00424749 |
Purpose
Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.
| Condition | Intervention | Phase |
|---|---|---|
|
Churg-Strauss Syndrome |
Drug: Rituximab Drug: Prednisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement |
| Enrollment: | 4 |
| Study Start Date: | June 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rituximab
375 mg/m^2/week for 4 weeks
|
Drug: Rituximab
Patients received 4 weekly doses of rituximab 375 mg/m^2.
Other Names:
Drug: Prednisone
Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months
Other Names:
|
Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of Rituximab in inducing remission of renal disease activity in patients with CSS.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Fernando C. Fervenza, M.D., Ph.D. | Mayo Clinic |
More Information
| Responsible Party: | Fernando Fervenza, MD, PhD, Professor of Medicine, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00424749 History of Changes |
| Other Study ID Numbers: | 06-004767, UL1RR024150 |
| Study First Received: | January 19, 2007 |
| Results First Received: | September 12, 2011 |
| Last Updated: | November 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Antineutrophil cytoplasmic antibody associated vasculitis Glomerulonephritis Rituximab |
|
Churg-Strauss Syndrome Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Systemic Vasculitis Vasculitis Vascular Diseases Cardiovascular Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases Autoimmune Diseases Immune System Diseases Prednisone Rituximab |
Antibodies, Antineutrophil Cytoplasmic Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Immunologic Factors Antirheumatic Agents |