NCT00103792

Brief Summary

The purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil. The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_3

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

Study Start

First participant enrolled

December 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2005

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

10 years

First QC Date

February 14, 2005

Last Update Submit

August 23, 2024

Conditions

Wegener's GranulomatosisVasculitis

Keywords

Induction therapyANCA-associated vasculitisWegener's granulomatosismicroscopic polyangiitismycophenolate mofetilcyclophosphamide

Outcome Measures

Primary Outcomes (2)

  • remission induction rate

    6 months

  • disease free survival after 2 and 4 years

    2 and 4 years

Secondary Outcomes (4)

  • time to remission

    9 months

  • cumulative organ damage

    4 years

  • side-effects

    4 years

  • ANCA titres over time

    4 years

Study Arms (2)

1 MMF induction

EXPERIMENTAL

mycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy

Drug: mycophenolate mofetil

2 CYC induction

ACTIVE COMPARATOR

cyclophosphamide and steroids, followed by maintenance therapy (azathioprine)

Drug: cyclophosphamide

Interventions

mycophenolate mofetilDRUG

2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy

1 MMF induction
cyclophosphamideDRUG

2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy

2 CYC induction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First or second relapse ANCA-associated vasculitis
  • PR3- or MPO-ANCA antibodies present or histological proof of relapse
  • Adult

You may not qualify if:

  • Severe alveolar bleeding or (imminent) respiratory failure
  • Renal failure (serum creatinine \>500 umol/L or dialysis)
  • Maintenance therapy before start of study consisting of: cyclophosphamide \> 100 mg/day or prednisolone \>25 mg/day
  • Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine
  • Gravidity or inadequate anticonception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

  • Stegeman CA; Cohen Tervaert JW. Mycophenolate mofetil for remission induction in patients with active Wegener's Granulomatosis (WG) intolerant for cyclophosphamide. J Am Soc Nephrol(11):98A, 2000

    BACKGROUND

MeSH Terms

Conditions

Granulomatosis with PolyangiitisVasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisMicroscopic Polyangiitis

Interventions

Mycophenolic AcidCyclophosphamide

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesSystemic VasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Coen Stegeman, MD PhD

    UMCG Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2005

First Posted

February 15, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

NL(1)