An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitis
Phase 2
Completed
- Conditions
- Wegener granulomatosis1003843010003816
- Registration Number
- NL-OMON29858
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
Inclusion Criteria
Active ANCA-associated vasculitis
Exclusion Criteria
Pregnancy and malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Endpoints<br /><br>Primary end points will be assessed upon trial completion at 2 years.<br /><br>However interim analyses will be performed when<br /><br>30 patients have completed 6 weeks, to assess efficacy (treatment response) and<br /><br>safety (severe adverse events).<br /><br>40 patients have completed 6 months to assess efficacy (remission rates) and<br /><br>safety (severe adverse events).<br /><br><br /><br>i Primary<br /><br>Sustained remission (BVAS = 0 at 6 months and sustained for 6 months).<br /><br>Severe adverse events (CTCAE grade >= 3) at 2 years.</p><br>
- Secondary Outcome Measures
Name Time Method <p>ii Secondary<br /><br>Efficacy<br /><br>Response rate at 6 weeks (BVAS < 50% baseline)<br /><br>Remission at 6 months (BVAS=0 for 2 months by 6 months)<br /><br>Time to remission (BVAS=0)<br /><br>Relapses (all relapses and major/minor)<br /><br>BVAS area under the curve<br /><br>Change in GFR<br /><br>Change in SF-36<br /><br>Change in VDI<br /><br><br /><br>Safety<br /><br>Severe adverse events (CTCAE grade >= 3) at 6 weeks and 6 months<br /><br>All adverse events<br /><br>Death<br /><br>Prednisolone cumulative dose<br /><br>Cyclophosphamide cumulative dose<br /><br>iii Tertiary<br /><br>Human anti-chimeric antibody testing<br /><br>Correlation of B cells with disease activity<br /><br>Change in ANCA and disease activity<br /><br>Histopathology predictors of outcome<br /><br></p><br>