Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
24 participants
INTERVENTIONAL
2011-02-28
2014-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alemtuzumab - high dose (60mg)
Alemtuzumab 30mg will be administered on Day 1 and Day 2 at 0 and 6 months
Alemtuzumab
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Alemtuzumab - low dose (30mg)
Alemtuzumab 15mg will be administered on Day 1 and Day 2 at 0 and 6 months
Alemtuzumab
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Interventions
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Alemtuzumab
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Active vasculitis with at least one severe or three non severe items of BVAS/WG activity (equivalent to BVAS/WG\>3)
3. Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone for at least 3 months.
Exclusion Criteria
2. Creatinine \> 150μmol/l (1.7mg/dl)
3. Total white count \< 4x109/l or lymphocyte count \< 0.5x109/l, or IgG \< 5g/L, or neutrophil count \< 1.5x109/l.
4. Severe lung haemorrhage with hypoxia (\<85% on room air)
5. Severe gastrointestinal, central nervous system or cardiac vasculitis
6. Previous therapy with:
1. Alemtuzumab at any time
2. IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or plasma exchange in past three months
3. Rituximab within the past 6 months
7. Intensive care unit requirement
8. Active infection with HIV, hepatitis B or hepatitis C or other infection requiring parenteral or long-term oral antibiotics
9. History of ITP or platelet count at screening below 50,000 x 106/l
10. Pregnancy or inadequate contraception in pre-menopausal women
11. Breast feeding
12. Any condition judged by the investigator that would cause the study to be detrimental to the patient.
13. Any other multisystem autoimmune disease including Churg Strauss angiitis, systemic lupus erythematosus, anti-GBM disease and cryoglobulinaemia
14. Any previous or current history of malignancy (other than resected basal cell carcinoma)
18 Years
60 Years
ALL
No
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Cambridge University Hospitals NHS Foundation Trust
Principal Investigators
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David RW Jayne, MD MRCP
Role: PRINCIPAL_INVESTIGATOR
Cambridge University Hospitals NHS Foundation Trust
Locations
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Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David RW Jayne, MD FRCP
Role: primary
References
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Gopaluni S, Smith R, Goymer D, Cahill H, Broadhurst E, Wallin E, McClure M, Chaudhry A, Jayne D. Alemtuzumab for refractory primary systemic vasculitis-a randomised controlled dose ranging clinical trial of efficacy and safety (ALEVIATE). Arthritis Res Ther. 2022 Apr 1;24(1):81. doi: 10.1186/s13075-022-02761-6.
Other Identifiers
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2009-017087-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AL1.1
Identifier Type: -
Identifier Source: org_study_id