A pilot study examining the effect of abatacept in ANCA associated vasculitis (AAV)
Phase 2
Completed
- Conditions
- ANCA Associated Vasculitis (AAV)Wegener granulomatosis100038161002321310047066
- Registration Number
- NL-OMON31540
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
Active ANCA-associated vasculitis
Exclusion Criteria
Pregnancy and malignancy, severe life threatening disease, renal insufficiency.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Response to treatment will be measured by:<br /><br>the relapse rates in patients who achieved remission over 24 month study period</p><br>
- Secondary Outcome Measures
Name Time Method <p>Response to treatment will also be measured by:<br /><br>- The proportion of patients in sustained remission at 6, 12, 18 months and 24<br /><br>months;<br /><br>- The time to remission;<br /><br>- The average steroid dosage at 6, 12, 18 and 24 months;<br /><br>- Proportion of patients switching to cyclophosphamide;<br /><br>- The time to ANCA negativity by immunofluorescence or negative anti-PR3 or<br /><br>anti-MPO Ab test by ELISA;<br /><br>- Urinary MCP-1 measurement to assess disease activity;<br /><br>- Quality of life scoring;<br /><br>- Vasculitis damage index scoring.</p><br>