Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis (MYCYC)
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ClinicalTrials.gov Identifier: NCT00414128 |
Recruitment Status :
Completed
First Posted : December 21, 2006
Last Update Posted : December 6, 2013
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | December 19, 2006 | |||||||||
First Posted Date ICMJE | December 21, 2006 | |||||||||
Last Update Posted Date | December 6, 2013 | |||||||||
Study Start Date ICMJE | March 2007 | |||||||||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Remission rates at 6 months [ Time Frame: 6 months ] Assessed by BVAS score of zero on 2 consecutive assessments
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Original Primary Outcome Measures ICMJE |
Remission rates at 6 months | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis | |||||||||
Official Title ICMJE | A Randomised Clinical Trial of Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in ANCA Associated Vasculitis. | |||||||||
Brief Summary | The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis. | |||||||||
Detailed Description | There is a clear need for improved therapy in ANCA associated vasculitis where current treatments are toxic and contribute to poor outcomes. Conventional therapy combines cyclophosphamide with prednisolone but is associated with severe adverse events in 35%, early mortality, malignancy and infertility. Mycophenolate mofetil (MMF) is a newer immunosuppressive drug which has superior efficacy to azathioprine in solid organ transplantation. MMF is an effective alternative to cyclophosphamide in lupus nephritis. Open label studies and retrospective surveys point to the efficacy and low toxicity of MMF in vasculitis. We hypothesise that MMF not be less effective than cyclophosphamide for remission induction in AASV. 140 new patients will be randomised to MMF 3g/day or a European consensus intravenous cyclophosphamide regimen, with the same prednisolone dosing. Following a six month induction course all patients will receive consensus remission maintenance treatment with azathioprine and prednisolone. The primary end-point will be remission rate by six months, secondary end-points include relapse rate at 18 months and safety. The trial will be conducted in 10 countries by members of the European Vasculitis Study Group (EUVAS). The trial duration will be 42 months (24 months recruitment, 18 months follow up). |
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Vasculitis | |||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Jones RB, Hiemstra TF, Ballarin J, Blockmans DE, Brogan P, Bruchfeld A, Cid MC, Dahlsveen K, de Zoysa J, Espigol-Frigole G, Lanyon P, Peh CA, Tesar V, Vaglio A, Walsh M, Walsh D, Walters G, Harper L, Jayne D; European Vasculitis Study Group (EUVAS). Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial. Ann Rheum Dis. 2019 Mar;78(3):399-405. doi: 10.1136/annrheumdis-2018-214245. Epub 2019 Jan 5. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
140 | |||||||||
Original Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date ICMJE | February 2013 | |||||||||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion (requires all):
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United Kingdom | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00414128 | |||||||||
Other Study ID Numbers ICMJE | MYCYC Eudract: 2006-001663-33 |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Current Responsible Party | David Jayne, Cambridge University Hospitals NHS Foundation Trust | |||||||||
Original Responsible Party | Not Provided | |||||||||
Current Study Sponsor ICMJE | Cambridge University Hospitals NHS Foundation Trust | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Cambridge University Hospitals NHS Foundation Trust | |||||||||
Verification Date | December 2013 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |