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Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)

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ClinicalTrials.gov Identifier: NCT00103792
Recruitment Status : Unknown
Verified February 2009 by University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : February 15, 2005
Last Update Posted : February 16, 2009
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Wegener's Granulomatosis Vasculitis Drug: mycophenolate mofetil Drug: cyclophosphamide Phase 3

Detailed Description:

Treatment of ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic drugs, and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. The standard induction therapy of a relapse of Wegener's granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone. Although this induction therapy is very effective, it is very toxic as well.

Searching for an alternative for cyclophosphamide, we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone. We will compare the effect and safety of the standard induction therapy with the new therapy. When relapses occur, patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis
Study Start Date : December 2004
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
mycophenolate and steroids as remission induction, followed by azathioprine maintenance therapy
Drug: mycophenolate mofetil
2000 mg mycophenolate per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
Active Comparator: 2
cyclophosphamide
Drug: cyclophosphamide
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy


Outcome Measures

Primary Outcome Measures :
  1. remission induction rate [ Time Frame: 6 months ]
  2. disease free survival after 2 and 4 years [ Time Frame: 2 and 4 years ]

Secondary Outcome Measures :
  1. time to remission [ Time Frame: 9 months ]
  2. cumulative organ damage [ Time Frame: 4 years ]
  3. side-effects [ Time Frame: 4 years ]
  4. ANCA titres over time [ Time Frame: 4 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103792


Contacts
Contact: Patricia M. Stassen, M.D., Ph.D. +31433876543 p.stassen@mumc.nl
Contact: Coen A. Stegeman, M.D., Ph.D. +31503616161 c.a.stegeman@int.umcg.nl

Locations
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Patricia Stassen, M.D.    +31503611295    p.m.stassen@int.umcg.nl   
Contact: Coen Stegeman, M.D., Ph. D.    +31503616161    c.a.stegeman@int.umcg.nl   
Sub-Investigator: Patricia Stassen, M.D. pH.D.         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Coen Stegeman, MD PhD UMCG Groningen
More Information

Publications:
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

Responsible Party: University Medical Center Groningen, Dept of Nephrology
ClinicalTrials.gov Identifier: NCT00103792     History of Changes
Other Study ID Numbers: WG-MMF-1
UMCG-ANCA-MMF-1
First Posted: February 15, 2005    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by University Medical Center Groningen:
Induction therapy
ANCA-associated vasculitis
Wegener's granulomatosis
microscopic polyangiitis
mycophenolate mofetil
cyclophosphamide

Additional relevant MeSH terms:
Vasculitis
Granulomatosis with Polyangiitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Microscopic Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cyclophosphamide
Azathioprine
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic