NCT01405807

Alemtuzumab for ANCA Associated Refractory Vasculitis

Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasculitis
• Microscopic Polyangiitis
• Granulomatosis With Polyangiitis
• Wegener's

Interventions

Type	Name	Description
DRUG	Alemtuzumab	Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-07-29
• Last updated: 2011-07-29

Locations

1 site across 1 country: United Kingdom