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Alemtuzumab for ANCA Associated Refractory Vasculitis

NCT01405807 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-07-29

No results posted yet for this study

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

DRUG

Alemtuzumab

Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months

Sponsors & Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • David RW Jayne, MD MRCP · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405807 on ClinicalTrials.gov