drugset / Trial / NCT01405807

Alemtuzumab for ANCA Associated Refractory Vasculitis

NCT01405807

RandomizedParallel-groupOpen-labelTreatment

Summary

Overview: This open label, randomized, multi-centre study will enroll and treat 24 patients with refractory AAV. Aims: To determine the clinical response and severe adverse event rates associated with alemtuzumab therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV). Hypothesis: Treatment with alemtuzumab induces sustained remission in AAV and will reduce immunosuppressive and steroid exposure.

Timeline

Start
2011-02
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 30 mg
Subject Alemtuzumab Monoclonal antibody 60 mg