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Differential Immune Effects of Natalizumab

Sponsor
Cantonal Hospital of St. Gallen (Other)
Overall Status
Completed
CT.gov ID
NCT00859482
Collaborator
(none)
27
Enrollment
12
Duration (Months)

Study Details

Study Description

Brief Summary

Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene 4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also with central nervous system (CNS) immune surveillance.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Longitudinal ex vivo and in vitro study to determine the effect of natalizumab on frequency of distinct immune cells and on the frequency and suppressive function of natural CD4+CD25+ regulatory T cells (Tregs).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    27 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Phase IV Study to Investigate Differential Immune Effects of Natalizumab
    Study Start Date :
    Jul 1, 2006
    Actual Primary Completion Date :
    Jul 1, 2007
    Actual Study Completion Date :
    Jul 1, 2007

    Outcome Measures

    Primary Outcome Measures

    1. Function of T regulatory cells [at month 3]

    Secondary Outcome Measures

    1. Change in distinct immune cell lines [month 3]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • relapsing remitting MS

    • indication for natalizumab treatment

    Exclusion Criteria:
    • other disease modifying agents within 2 weeks

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cantonal Hospital of St. Gallen

    Investigators

    • Principal Investigator: Norman Putzki, MD, KSSG, 9007 St. Gallen, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00859482
    Other Study ID Numbers:
    • Ntz-Tregs1
    First Posted:
    Mar 11, 2009
    Last Update Posted:
    Mar 11, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    natalizumab
    multiple sclerosis
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis

    Study Results

    No Results Posted as of Mar 11, 2009