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

December 5, 2013 updated by: David Jayne, Cambridge University Hospitals NHS Foundation Trust

A Randomised Clinical Trial of Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in ANCA Associated Vasculitis.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB22QQ
        • Addenbrookes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • cytoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission rates at 6 months
Time Frame: 6 months
Assessed by BVAS score of zero on 2 consecutive assessments
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

Vifor Pharma
Aspreva Pharmaceuticals

Investigators

  • Principal Investigator: David Jayne, Addenbrooke's Hospital, Cambridge, UK
  • Principal Investigator: Lorraine Harper, Birmingham University, UK
  • Principal Investigator: Rachel Jones, Addenbrooke's Hospital, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYCYC
  • Eudract: 2006-001663-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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