Alemtuzumab for ANCA Associated Refractory Vasculitis (ALEVIATE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01405807 |
Recruitment Status
: Unknown
Verified July 2011 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted
: July 29, 2011
Last Update Posted
: July 29, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vasculitis Microscopic Polyangiitis Granulomatosis With Polyangiitis Wegener's | Drug: Alemtuzumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | March 2014 |
Estimated Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Alemtuzumab - high dose (60mg)
Alemtuzumab 30mg will be administered on Day 1 and Day 2 at 0 and 6 months
|
Drug: Alemtuzumab
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Other Name: Campath 1H
|
Experimental: Alemtuzumab - low dose (30mg)
Alemtuzumab 15mg will be administered on Day 1 and Day 2 at 0 and 6 months
|
Drug: Alemtuzumab
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Other Name: Campath 1H
|
- 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.
- Proportion of patients with a severe adverse event [ Time Frame: 6 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
- Combined damage assessment (CDA) scores [ Time Frame: 12 months ]
- Non severe adverse events [ Time Frame: 12 months ]
- Cumulative dose of corticosteroids [ Time Frame: 12 months ]
- Time to remission [ Time Frame: 6 months ]Complete and partial
- Relapse [ Time Frame: 12 months ]
- Change in SF-36 [ Time Frame: 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405807
Contact: David RW Jayne, MD FRCP | 00441223586796 | dj106@cam.ac.uk | |
Contact: Rona M Smith, MA MRCP | 00441223217259 | ronasmith@doctors.net.uk |
United Kingdom | |
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust | Recruiting |
Cambridge, United Kingdom, CB20QQ | |
Contact: David RW Jayne, MD FRCP 00441223586796 dj106@cam.ac.uk | |
Principal Investigator: David RW Jayne, MD FRCP |
Principal Investigator: | David RW Jayne, MD MRCP | Cambridge University Hospitals NHS Foundation Trust |
Responsible Party: | Dr David Jayne, Cambridge University Hospitals NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT01405807 History of Changes |
Other Study ID Numbers: |
AL1.1 2009-017087-17 ( EudraCT Number ) |
First Posted: | July 29, 2011 Key Record Dates |
Last Update Posted: | July 29, 2011 |
Last Verified: | July 2011 |
Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Vasculitis ANCA Refractory |
Additional relevant MeSH terms:
Vasculitis Systemic Vasculitis Granulomatosis with Polyangiitis Microscopic Polyangiitis Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
Autoimmune Diseases Immune System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Alemtuzumab Antineoplastic Agents |