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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: |
NCT00103792 |
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Date of registration:
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14/02/2005 |
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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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Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)
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Scientific title:
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Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00103792 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Patricia Stassen, M.D. |
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Address:
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Telephone:
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+31503611295 |
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Email:
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p.m.stassen@int.umcg.nl |
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Affiliation:
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Name:
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Patricia M. Stassen, M.D., Ph.D. |
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Address:
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Telephone:
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+31433876543 |
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Email:
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p.stassen@mumc.nl |
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Affiliation:
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Name:
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Coen Stegeman, MD 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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UMCG Groningen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- First or second relapse ANCA-associated vasculitis
- PR3- or MPO-ANCA antibodies present or histological proof of relapse
- Adult
Exclusion Criteria:
- Severe alveolar bleeding or (imminent) respiratory failure
- Renal failure (serum creatinine >500 umol/L or dialysis)
- Maintenance therapy before start of study consisting of: cyclophosphamide > 100
mg/day or prednisolone >25 mg/day
- Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine
- Gravidity or inadequate anticonception
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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Vasculitis
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Wegener's Granulomatosis
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Intervention(s)
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Drug: cyclophosphamide
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Drug: mycophenolate mofetil
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Primary Outcome(s)
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disease free survival after 2 and 4 years
[Time Frame: 2 and 4 years]
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remission induction rate
[Time Frame: 6 months]
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Secondary Outcome(s)
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cumulative organ damage
[Time Frame: 4 years]
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side-effects
[Time Frame: 4 years]
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ANCA titres over time
[Time Frame: 4 years]
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time to remission
[Time Frame: 9 months]
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Secondary ID(s)
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UMCG-ANCA-MMF-1
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WG-MMF-1
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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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