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 Information
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
Administrative Informations
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