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

Primary Purpose

Vasculitis

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

mycophenolate mofetil

cyclophosphamide

About this trial

This is an interventional treatment trial for Vasculitis focused on measuring vasculitis, ANCA, mycophenolate mofetil, cyclophosphamide, Anti neutrophil cytoplasm antibody associated vasculitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Addenbrookes Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mycophenolate mofetil

cyclophosphamide

Arm Description

Mycophenolate mofetil for 3-6 months until in stable remission, dose 2-3g/day

pulsed intravenous cyclophosphamide 15mg/kg for 3-6 months (6-10 doses)until in stable remission

Outcomes

Primary Outcome Measures

Remission rates at 6 months

Assessed by BVAS score of zero on 2 consecutive assessments

Secondary Outcome Measures

Full Information

NCT ID

NCT00414128

First Posted

December 19, 2006

Last Updated

December 5, 2013

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

Aspreva Pharmaceuticals, Vifor Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00414128

Brief Title

Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

Acronym

MYCYC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

Aspreva Pharmaceuticals, Vifor Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vasculitis

Keywords

vasculitis, ANCA, mycophenolate mofetil, cyclophosphamide, Anti neutrophil cytoplasm antibody associated vasculitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mycophenolate mofetil

Arm Type

Experimental

Arm Description

Mycophenolate mofetil for 3-6 months until in stable remission, dose 2-3g/day

Arm Title

cyclophosphamide

Arm Type

Active Comparator

Arm Description

pulsed intravenous cyclophosphamide 15mg/kg for 3-6 months (6-10 doses)until in stable remission

Intervention Type

Drug

Intervention Name(s)

mycophenolate mofetil

Other Intervention Name(s)

Cellcept

Intervention Description

2-3g/day for 3-6 months, in tablet, capsule or liquid form

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Other Intervention Name(s)

cytoxan

Intervention Description

intravenous cyclophosphamide, 15mg/kg with dose reductions according to age and renal function, for 3-6 months (6-10 doses total)

Primary Outcome Measure Information:

Title

Remission rates at 6 months

Description

Assessed by BVAS score of zero on 2 consecutive assessments

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Jayne

Organizational Affiliation

Addenbrooke's Hospital, Cambridge, UK

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lorraine Harper

Organizational Affiliation

Birmingham University, UK

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rachel Jones

Organizational Affiliation

Addenbrooke's Hospital, UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Addenbrookes Hospital

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB22QQ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30612116

Citation

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.

Results Reference

derived

Links:

URL

http://vasculitis.org

Description

EUVAS web site

Learn more about this trial

Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

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