Alemtuzumab for ANCA Associated Refractory Vasculitis (ALEVIATE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2011 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Cambridge University Hospitals NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01405807

First received: July 27, 2011

Last updated: July 28, 2011

Last verified: July 2011

History of Changes

Purpose

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	Intervention	Phase
Vasculitis Microscopic Polyangiitis Granulomatosis With Polyangiitis Wegener's	Drug: Alemtuzumab	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: granulomatosis with polyangiitis

MedlinePlus related topics: Vasculitis

Drug Information available for: Alemtuzumab

Genetic and Rare Diseases Information Center resources: Granulomatosis With Polyangiitis Microscopic Polyangiitis ANCA-associated Vasculitis

U.S. FDA Resources

Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	24
Study Start Date:	February 2011
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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:
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
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)

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405807

Contacts


Contact: David RW Jayne, MD FRCP	00441223586796	dj106@cam.ac.uk
Contact: Rona M Smith, MA MRCP	00441223217259	ronasmith@doctors.net.uk

Locations


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

Sponsors and Collaborators

Cambridge University Hospitals NHS Foundation Trust

Investigators


Principal Investigator:	David RW Jayne, MD MRCP	Cambridge University Hospitals NHS Foundation Trust

More Information


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 )
Study First Received:	July 27, 2011
Last Updated:	July 28, 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

ClinicalTrials.gov processed this record on September 21, 2017

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