Differential Immune Effects of Natalizumab

A Phase IV Study to Investigate Differential Immune Effects of Natalizumab

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00859482

Enrollment

Registered

2009-03-11

Start date

2006-07-31

Completion date

2007-07-31

Last updated

2009-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing Remitting

Keywords

natalizumab, multiple sclerosis

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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* relapsing remitting MS * indication for natalizumab treatment

Exclusion criteria

* other disease modifying agents within 2 weeks

Design outcomes

Primary

Measure	Time frame
Function of T regulatory cells	at month 3

Secondary

Measure	Time frame
Change in distinct immune cell lines	month 3

Outcome results