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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy
- remission induction rate [ Time Frame: 6 months ]
- disease free survival after 2 and 4 years [ Time Frame: 2 and 4 years ]
- time to remission [ Time Frame: 9 months ]
- cumulative organ damage [ Time Frame: 4 years ]
- side-effects [ Time Frame: 4 years ]
- ANCA titres over time [ Time Frame: 4 years ]
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
|Contact: Patricia M. Stassen, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Coen A. Stegeman, M.D., Ph.D.||+email@example.com|
|University Medical Centre Groningen||Recruiting|
|Groningen, Netherlands, 9700 RB|
|Contact: Patricia Stassen, M.D. +31503611295 firstname.lastname@example.org|
|Contact: Coen Stegeman, M.D., Ph. D. +31503616161 email@example.com|
|Sub-Investigator: Patricia Stassen, M.D. pH.D.|
|Principal Investigator:||Coen Stegeman, MD PhD||UMCG Groningen|