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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.
 
ClinicalTrials.gov Identifier: NCT00414128
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : December 6, 2013
Sponsor:
Collaborators:
Aspreva Pharmaceuticals
Vifor Pharma
Information provided by (Responsible Party):
David Jayne, Cambridge University Hospitals NHS Foundation Trust

Tracking Information
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
 (submitted: December 5, 2013)		 Remission rates at 6 months [ Time Frame: 6 months ]
Assessed by BVAS score of zero on 2 consecutive assessments
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2006)		 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vasculitis
Intervention  ICMJE
  • Drug: mycophenolate mofetil
    2-3g/day for 3-6 months, in tablet, capsule or liquid form
    Other Name: Cellcept
  • 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
Study Arms  ICMJE
  • Experimental: mycophenolate mofetil
    Mycophenolate mofetil for 3-6 months until in stable remission, dose 2-3g/day
    Intervention: Drug: mycophenolate mofetil
  • Active Comparator: cyclophosphamide
    pulsed intravenous cyclophosphamide 15mg/kg for 3-6 months (6-10 doses)until in stable remission
    Intervention: Drug: cyclophosphamide
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2006)		 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):

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
  • Aspreva Pharmaceuticals
  • Vifor Pharma
Investigators  ICMJE
Principal Investigator: David Jayne Addenbrooke's Hospital, Cambridge, UK
Principal Investigator: Lorraine Harper Birmingham University, UK
Principal Investigator: Rachel Jones Addenbrooke's Hospital, UK
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