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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
Sponsor:
Information provided by:
Cambridge University Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE July 27, 2011
First Posted Date  ICMJE July 29, 2011
Last Update Posted Date July 29, 2011
Study Start Date  ICMJE February 2011
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alemtuzumab for ANCA Associated Refractory Vasculitis
Official Title  ICMJE Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy
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 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vasculitis
  • Microscopic Polyangiitis
  • Granulomatosis With Polyangiitis
  • Wegener's
Intervention  ICMJE Drug: Alemtuzumab
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
Other Name: Campath 1H
Study Arms  ICMJE
  • Experimental: Alemtuzumab - high dose (60mg)
    Alemtuzumab 30mg will be administered on Day 1 and Day 2 at 0 and 6 months
    Intervention: Drug: Alemtuzumab
  • Experimental: Alemtuzumab - low dose (30mg)
    Alemtuzumab 15mg will be administered on Day 1 and Day 2 at 0 and 6 months
    Intervention: Drug: Alemtuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2011)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A diagnosis of AAV, according to a standardized definition
  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:

  1. Age less than 18 or greater than 60 years
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01405807
Other Study ID Numbers  ICMJE AL1.1
2009-017087-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr David Jayne, Cambridge University Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Cambridge University Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David RW Jayne, MD MRCP Cambridge University Hospitals NHS Foundation Trust
PRS Account Cambridge University Hospitals NHS Foundation Trust
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP