Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with a vasculitis response at 6 months
Response includes patients in complete and partial remission. Complete remission (CR) is defined as a BVAS/WG of 0 for at least one month. Partial response (PR) is the absence of severe BVAS/WG items and at least 50% fall in BVAS/WG score from baseline.
David RW Jayne, MD MRCP
Cambridge University Hospitals NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency