drugset / Trial / NCT01405807
Alemtuzumab for ANCA Associated Refractory Vasculitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | — |
| Subject | Alemtuzumab | Monoclonal antibody | 60 mg | — |