Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides
Study Details
Study Description
Brief Summary
The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold standard therapy for SNV is currently represented by the association of Cyclophosphamide and Prednisone. The limits of this approach are the high frequency of recurrent disease and an increased incidence of malignancy and infections. The aim of the present study is to compare the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A Cyclophosphamide |
Drug: Cyclophosphamide
|
| Experimental: B Methotrexate |
Drug: Methotrexate
|
Outcome Measures
Primary Outcome Measures
- Time from remission to relapse []
Secondary Outcome Measures
- Recurrence rate []
- Therapy-related toxicity []
- Hospitalization rate []
- Mortality []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of clinically active SNV
-
Life-expectancy > 1 year
-
Written informed consent
Exclusion Criteria:
-
Creatinine clearance < 10 ml/min/1.73 mq
-
Aminotransferase levels more than twice the upper limit of the normal range
-
HBsAg positivity
-
anti-HCV Ig and HCV-RNA positivity
-
HIV positivity
-
Active malignancies
-
Coexistence of connective tissue disease
-
Prednisolone, cyclophosphamide or methotrexate hypersensitivity
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital | Parma | Italy/Parma | Italy | 43100 |
Sponsors and Collaborators
- University of Parma
Investigators
- Principal Investigator: Carlo Buzio, MD, University of Parma
Study Documents (Full-Text)
None provided.More Information
Publications
- Falk RJ, Jennette JC. ANCA small-vessel vasculitis. J Am Soc Nephrol. 1997 Feb;8(2):314-22. Review.
- Gordon M, Luqmani RA, Adu D, Greaves I, Richards N, Michael J, Emery P, Howie AJ, Bacon PA. Relapses in patients with a systemic vasculitis. Q J Med. 1993 Dec;86(12):779-89.
- Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98.
- Hoffman GS. Wegener's granulomatosis. Curr Opin Rheumatol. 1993 Jan;5(1):11-7. Review.
- Talar-Williams C, Hijazi YM, Walther MM, Linehan WM, Hallahan CW, Lubensky I, Kerr GS, Hoffman GS, Fauci AS, Sneller MC. Cyclophosphamide-induced cystitis and bladder cancer in patients with Wegener granulomatosis. Ann Intern Med. 1996 Mar 1;124(5):477-84.
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