A Phase 3 interventional study of mycophenolate mofetil and cyclophosphamide in Wegener's Granulomatosis and Vasculitis, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by University Medical Center Groningen · Phase 3, Interventional, and Treatment
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.
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.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 16 are open to participants now.
This study's enrollment of 84 is above the median of 70 across 69 interventional studies indexed under Granulomatosis with Polyangiitis.
Browse Granulomatosis with Polyangiitis studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
mycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy
Drug: mycophenolate mofetil
cyclophosphamide and steroids, followed by maintenance therapy (azathioprine)
Drug: cyclophosphamide
2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy
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
Plan to share: Undecided
Ran from Dec 2004 to primary completion in Dec 2014, 120 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mycophenolic Acid
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