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

Brief Title

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

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

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.
    

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

remission induction rate

Secondary Outcome

 time to remission

Condition

Wegener's Granulomatosis

Intervention

mycophenolate mofetil

Study Arms / Comparison Groups

 1

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

90

Start Date

December 2004

Completion Date

January 2012

Primary Completion Date

January 2010

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Coen Stegeman, MD PhD, +31433876543, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

NCT ID

NCT00103792

Organization ID

WG-MMF-1

Secondary IDs

UMCG-ANCA-MMF-1

Study Sponsor

University Medical Center Groningen

Study Sponsor

Coen Stegeman, MD PhD, Principal Investigator, UMCG Groningen

Verification Date

February 2009