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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00751517 |
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Date of registration:
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11/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides
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Scientific title:
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Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial. |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00751517 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Carlo Buzio, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Parma |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Microscopic Polyangiitis
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Polyarteritis Nodosa
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Wegener's Granulomatosis
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Churg-Strauss Syndrome
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: Methotrexate
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Primary Outcome(s)
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Time from remission to relapse
[Time Frame: No]
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Secondary Outcome(s)
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Therapy-related toxicity
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Recurrence rate
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Hospitalization rate
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Mortality
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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