Alemtuzumab for ANCA-Associated Refractory Vasculitis - A study of safety and efficacy (ALEVIATE). - Alemtuzumab for ANCA-Associated Refractory Vasculitis

Phase 1

• Conditions: ANCA-associated vasculitis (AAV); MedDRA version: 12 Level: LLT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis

• Registration Number: EUCTR2009-017087-17-GB
• Lead Sponsor: Addenbrooke's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-19
• Study Completion: 2018-05-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1) A diagnosis of ANCA associated vasculitis
2) Active vasculitis with a least one severe or three non-severe items of BVAS/WG activity (a validated disease activity measure)
3) Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone, for at least 3 months
4) Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Age less than 18 years or greater than 60 years
2) Creatinine > 150µmol/l
3) Total white cell count < 4x10^9/l or lymphocyte count < 0.5x10^9/l or neutrophil count < 1.5x10^9/l or IgG < 5g/l
4) Severe lung haemorrhage with hypoxia (oxygen saturations < 85% on room air)
5) Severe gastrointestinal, central nervous system or cardiac vasculitis
6) Previous therapy with:
a) Alemtuzumab at any time
b) IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or plasma exchange in the past 3 months
c) Rituximab within the past 6 months
7) Intensive care unit requirement
8) Active infection with HIV, hepatitis B or C or other infection requiring parenteral or long term oral antibiotics
9) History of ITP or platelet count at screening below 50,000 x10^6/l
10) Pregnancy or inadequate contraception in pre-menopausal women
11) Breast feeding
12) Previous history of malignancy
13) Any other mulitsystem autoimmune disease, including Churg Strauss angiitis, systemic lupus erythematosus, anti-GBM disease and cryoglobulinaemia
14) Any condition judged by the investigator that would cause the study to be detrimental to the patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified