Differential Immune Effects of Natalizumab

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

relapsing remitting MS
indication for natalizumab treatment

Exclusion criteria

other disease modifying agents within 2 weeks

Treatment and study plan

Primary outcomes

Function of T regulatory cells

Time frame: at month 3

Secondary outcomes

Change in distinct immune cell lines

Time frame: month 3

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

A Phase IV Study to Investigate Differential Immune Effects of Natalizumab

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Mar 11, 2009
Registry last updated: Mar 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed