Status:
UNKNOWN
Alemtuzumab for ANCA Associated Refractory Vasculitis
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Vasculitis
Microscopic Polyangiitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 w...
Eligibility Criteria
Inclusion
- A diagnosis of AAV, according to a standardized definition
- Active vasculitis with at least one severe or three non severe items of BVAS/WG activity (equivalent to BVAS/WG\>3)
- Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone for at least 3 months.
Exclusion
- Age less than 18 or greater than 60 years
- Creatinine \> 150μmol/l (1.7mg/dl)
- Total white count \< 4x109/l or lymphocyte count \< 0.5x109/l, or IgG \< 5g/L, or neutrophil count \< 1.5x109/l.
- Severe lung haemorrhage with hypoxia (\<85% on room air)
- Severe gastrointestinal, central nervous system or cardiac vasculitis
- Previous therapy with:
- Alemtuzumab at any time
- IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or plasma exchange in past three months
- Rituximab within the past 6 months
- Intensive care unit requirement
- Active infection with HIV, hepatitis B or hepatitis C or other infection requiring parenteral or long-term oral antibiotics
- History of ITP or platelet count at screening below 50,000 x 106/l
- Pregnancy or inadequate contraception in pre-menopausal women
- Breast feeding
- Any condition judged by the investigator that would cause the study to be detrimental to the patient.
- Any other multisystem autoimmune disease including Churg Strauss angiitis, systemic lupus erythematosus, anti-GBM disease and cryoglobulinaemia
- Any previous or current history of malignancy (other than resected basal cell carcinoma)
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01405807
Start Date
February 1 2011
End Date
March 1 2014
Last Update
July 29 2011
Active Locations (1)
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1
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, United Kingdom, CB20QQ