Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides
Primary Purpose
Wegener's Granulomatosis, Churg-Strauss Syndrome, Microscopic Polyangiitis
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Methotrexate
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Wegener's Granulomatosis focused on measuring Vasculitis, Cyclophosphamide, Methotrexate, Systemic Necrotizing Vasculitides
Eligibility 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
Sites / Locations
- Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Cyclophosphamide
Methotrexate
Outcomes
Primary Outcome Measures
Time from remission to relapse
Secondary Outcome Measures
Recurrence rate
Therapy-related toxicity
Hospitalization rate
Mortality
Full Information
NCT ID
NCT00751517
First Posted
September 11, 2008
Last Updated
September 11, 2008
Sponsor
University of Parma
1. Study Identification
Unique Protocol Identification Number
NCT00751517
Brief Title
Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides
Official Title
Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Parma
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wegener's Granulomatosis, Churg-Strauss Syndrome, Microscopic Polyangiitis, Polyarteritis Nodosa
Keywords
Vasculitis, Cyclophosphamide, Methotrexate, Systemic Necrotizing Vasculitides
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Cyclophosphamide
Arm Title
B
Arm Type
Experimental
Arm Description
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Primary Outcome Measure Information:
Title
Time from remission to relapse
Secondary Outcome Measure Information:
Title
Recurrence rate
Title
Therapy-related toxicity
Title
Hospitalization rate
Title
Mortality
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Buzio, MD
Organizational Affiliation
University of Parma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
City
Parma
State/Province
Italy/Parma
ZIP/Postal Code
43100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
1739240
Citation
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. doi: 10.7326/0003-4819-116-6-488.
Results Reference
background
PubMed Identifier
8435284
Citation
Hoffman GS. Wegener's granulomatosis. Curr Opin Rheumatol. 1993 Jan;5(1):11-7. doi: 10.1097/00002281-199305010-00003.
Results Reference
background
PubMed Identifier
7906421
Citation
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.
Results Reference
background
PubMed Identifier
9048352
Citation
Falk RJ, Jennette JC. ANCA small-vessel vasculitis. J Am Soc Nephrol. 1997 Feb;8(2):314-22. doi: 10.1681/ASN.V82314. No abstract available.
Results Reference
background
PubMed Identifier
8602705
Citation
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. doi: 10.7326/0003-4819-124-5-199603010-00003.
Results Reference
background
PubMed Identifier
29016646
Citation
Maritati F, Alberici F, Oliva E, Urban ML, Palmisano A, Santarsia F, Andrulli S, Pavone L, Pesci A, Grasselli C, Santi R, Tumiati B, Manenti L, Buzio C, Vaglio A. Methotrexate versus cyclophosphamide for remission maintenance in ANCA-associated vasculitis: A randomised trial. PLoS One. 2017 Oct 10;12(10):e0185880. doi: 10.1371/journal.pone.0185880. eCollection 2017.
Results Reference
derived
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Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides
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