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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: |
NCT00753103 |
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Date of registration:
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15/09/2008 |
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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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Anti-Cytokine Therapy for Vasculitis
ACTIVE |
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Scientific title:
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Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00753103 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/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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United Kingdom
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Contacts
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Name:
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Lorraine Harper, PhD |
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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 Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's
granulomatosis, microscopic polyangiitis, renal limited vasculitis)
Exclusion Criteria:
- Active infection
- Malignancy
- Pregnancy
- Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody
disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wegener's Granulomatosis
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Renal Limited Vasculitis
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Microscopic Polyangiitis
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Intervention(s)
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Drug: Methylprednisolone
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Procedure: Plasma exchange
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Drug: Prednisolone
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Drug: Cyclophosphamide
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Drug: Azathioprine
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Biological: Infliximab
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Drug: Mycophenolate mofetil
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Primary Outcome(s)
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Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
[Time Frame: 0, 6, 10, 14, 26, 39 and 52 weeks]
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Secondary Outcome(s)
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Adverse events
[Time Frame: Weeks 2, 6, 10, 14, 26, 39, 52]
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Renal function
[Time Frame: Weeks 0, 2, 6, 10, 14, 26, 39, 52]
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Vasculitis Damage Index Score
[Time Frame: Weeks 0, 14, 26, 39, 52]
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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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