CompletedPhase 3

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

Netherlands84 participantsStarted 2004-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

remission induction rate

Timeframe: 6 months

disease free survival after 2 and 4 years

Timeframe: 2 and 4 years

Trial details

NCT IDNCT00103792

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

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