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Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis (MYCYC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414128
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : December 6, 2013
Aspreva Pharmaceuticals
Vifor Pharma
Information provided by (Responsible Party):
David Jayne, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.

Condition or disease Intervention/treatment Phase
Vasculitis Drug: mycophenolate mofetil Drug: cyclophosphamide Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Clinical Trial of Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in ANCA Associated Vasculitis.
Study Start Date : March 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: mycophenolate mofetil
Mycophenolate mofetil for 3-6 months until in stable remission, dose 2-3g/day
Drug: mycophenolate mofetil
2-3g/day for 3-6 months, in tablet, capsule or liquid form
Other Name: Cellcept

Active Comparator: cyclophosphamide
pulsed intravenous cyclophosphamide 15mg/kg for 3-6 months (6-10 doses)until in stable remission
Drug: cyclophosphamide
intravenous cyclophosphamide, 15mg/kg with dose reductions according to age and renal function, for 3-6 months (6-10 doses total)
Other Name: cytoxan

Primary Outcome Measures :
  1. Remission rates at 6 months [ Time Frame: 6 months ]
    Assessed by BVAS score of zero on 2 consecutive assessments

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Inclusion (requires all):

  • New diagnosis of AASV (WG or MPA) (within the previous six months)
  • Active disease (defined by at least one major or three minor BVAS 2003 items, see appendix 1)
  • ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (see appendix )
  • Written informed consent

Exclusion Criteria:

  • Previous treatment with:

    • MMF: more than two weeks ever.
    • Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of IV CYC (15mg/kg)
    • Rituximab or high dose intravenous immunoglobulin within the last twelve months
  • Active infection (including hepatitis B, C, HIV and tuberculosis).
  • Known hypersensitivity to MMF, AZA or CYC.
  • Cancer or an individual history of cancer (other than resected basal cell skin carcinoma).
  • Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
  • Any condition judged by the investigator that would cause the study to be detrimental to the patient.
  • Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulinaemia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414128

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United Kingdom
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB22QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Aspreva Pharmaceuticals
Vifor Pharma
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Principal Investigator: David Jayne Addenbrooke's Hospital, Cambridge, UK
Principal Investigator: Lorraine Harper Birmingham University, UK
Principal Investigator: Rachel Jones Addenbrooke's Hospital, UK
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Jayne, Drs David Jayne Consultant in Nephrology and Vasculitis, Cambridge University Hospitals NHS Foundation Trust Identifier: NCT00414128    
Other Study ID Numbers: MYCYC
Eudract: 2006-001663-33
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by David Jayne, Cambridge University Hospitals NHS Foundation Trust:
mycophenolate mofetil
Anti neutrophil cytoplasm antibody associated vasculitis
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors