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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 Summary:

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.


Sponsor: University Medical Center Groningen

Current Primary Outcome:

  • remission induction rate [ Time Frame: 6 months ]
  • disease free survival after 2 and 4 years [ Time Frame: 2 and 4 years ]


Original Primary Outcome:

  • remission induction rate
  • disease free survival after 2 and 4 years


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • time to remission
  • cumulative organ damage
  • side-effects
  • ANCA titres over time


Information By: University Medical Center Groningen

Dates:
Date Received: February 14, 2005
Date Started: December 2004
Date Completion: January 2012
Last Updated: February 12, 2009
Last Verified: February 2009