- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01405807
Alemtuzumab for ANCA Associated Refractory Vasculitis (ALEVIATE)
Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: David RW Jayne, MD FRCP
- Phone Number: 00441223586796
- Email: dj106@cam.ac.uk
Study Contact Backup
- Name: Rona M Smith, MA MRCP
- Phone Number: 00441223217259
- Email: ronasmith@doctors.net.uk
Study Locations
-
-
-
Cambridge, United Kingdom, CB20QQ
- Recruiting
- Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
-
Contact:
- David RW Jayne, MD FRCP
- Phone Number: 00441223586796
- Email: dj106@cam.ac.uk
-
Principal Investigator:
- David RW Jayne, MD FRCP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alemtuzumab - high dose (60mg)
Alemtuzumab 30mg will be administered on Day 1 and Day 2 at 0 and 6 months
|
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Other Names:
|
Experimental: Alemtuzumab - low dose (30mg)
Alemtuzumab 15mg will be administered on Day 1 and Day 2 at 0 and 6 months
|
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with a vasculitis response at 6 months
Time Frame: 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.
|
6 months
|
Proportion of patients with a severe adverse event
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse
Time Frame: 12 months
|
12 months
|
|
Proportion of patients with treatment failure
Time Frame: 12 months
|
Treatment failure is defined as the failure to achieve a vasculitis response by six months or a vasculitis relapse between 6 and 12 months
|
12 months
|
Combined damage assessment (CDA) scores
Time Frame: 12 months
|
12 months
|
|
Non severe adverse events
Time Frame: 12 months
|
12 months
|
|
Cumulative dose of corticosteroids
Time Frame: 12 months
|
12 months
|
|
Time to remission
Time Frame: 6 months
|
Complete and partial
|
6 months
|
Change in SF-36
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: David RW Jayne, MD MRCP, Cambridge University Hospitals NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases
- Lung Diseases
- Lung Diseases, Interstitial
- Cerebral Small Vessel Diseases
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Vasculitis
- Granulomatosis with Polyangiitis
- Microscopic Polyangiitis
- Systemic Vasculitis
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Alemtuzumab
Other Study ID Numbers
- AL1.1
- 2009-017087-17 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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