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

Phase 3

Completed

• Conditions: Wegener's Granulomatosis; Vasculitis

• Registration Number: NCT00103792
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-2-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - First or second relapse ANCA-associated vasculitis<br><br> - PR3- or MPO-ANCA antibodies present or histological proof of relapse<br><br> - Adult<br><br>Exclusion Criteria:<br><br> - Severe alveolar bleeding or (imminent) respiratory failure<br><br> - Renal failure (serum creatinine >500 umol/L or dialysis)<br><br> - Maintenance therapy before start of study consisting of: cyclophosphamide > 100<br> mg/day or prednisolone >25 mg/day<br><br> - Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine<br><br> - Gravidity or inadequate anticonception

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
remission induction rate;disease free survival after 2 and 4 years

Secondary Outcome Measures

Name	Time	Method
time to remission;cumulative organ damage;side-effects;ANCA titres over time