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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, United Kingdom
RECRUITINGProportion 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.
Time frame: 6 months
Proportion of patients with a severe adverse event
Time frame: 6 months
Proportion of patients with treatment failure
Treatment failure is defined as the failure to achieve a vasculitis response by six months or a vasculitis relapse between 6 and 12 months
Time frame: 12 months
Combined damage assessment (CDA) scores
Time frame: 12 months
Non severe adverse events
Time frame: 12 months
Cumulative dose of corticosteroids
Time frame: 12 months
Time to remission
Complete and partial
Time frame: 6 months
Relapse
Time frame: 12 months
Change in SF-36
Time frame: 12 months
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