NCT00414128

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

4.3 years

First QC Date

December 19, 2006

Last Update Submit

December 5, 2013

Conditions

Vasculitis

Keywords

vasculitisANCAmycophenolate mofetilcyclophosphamideAnti neutrophil cytoplasm antibody associated vasculitis

Outcome Measures

Primary Outcomes (1)

  • Remission rates at 6 months

    Assessed by BVAS score of zero on 2 consecutive assessments

    6 months

Study Arms (2)

mycophenolate mofetil

EXPERIMENTAL

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

Drug: mycophenolate mofetil

cyclophosphamide

ACTIVE COMPARATOR

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

Drug: cyclophosphamide

Interventions

mycophenolate mofetilDRUG

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

Also known as: Cellcept
mycophenolate mofetil
cyclophosphamideDRUG

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

Also known as: cytoxan
cyclophosphamide

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB22QQ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30612116DERIVED

Related Links

MeSH Terms

Conditions

Vasculitis

Interventions

Mycophenolic AcidCyclophosphamide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • David Jayne

    Addenbrooke's Hospital, Cambridge, UK

    PRINCIPAL INVESTIGATOR

  • Lorraine Harper

    Birmingham University, UK

    PRINCIPAL INVESTIGATOR

  • Rachel Jones

    Addenbrooke's Hospital, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs David Jayne Consultant in Nephrology and Vasculitis

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Study Start

March 1, 2007

Primary Completion

July 1, 2011

Study Completion

February 1, 2013

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations

GB(1)