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Differential Immune Effects of Natalizumab

Information source: Cantonal Hospital of St. Gallen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing Remitting

Phase: N/A

Status: Completed

Sponsored by: Cantonal Hospital of St. Gallen

Official(s) and/or principal investigator(s):
Norman Putzki, MD, Principal Investigator, Affiliation: KSSG, 9007 St. Gallen, Switzerland

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.

Clinical Details

Official title: A Phase IV Study to Investigate Differential Immune Effects of Natalizumab

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Function of T regulatory cells

Secondary outcome: Change in distinct immune cell lines

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).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- relapsing remitting MS

- indication for natalizumab treatment

Exclusion Criteria:

- other disease modifying agents within 2 weeks

Locations and Contacts

Additional Information

Starting date: July 2006
Last updated: March 10, 2009

Page last updated: August 23, 2015

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