Differential Immune Effects of Natalizumab

Multiple Sclerosis, Relapsing Remitting Clinical Trial

Official title:

A Phase IV Study to Investigate Differential Immune Effects of Natalizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859482
• Other study ID #: Ntz-Tregs1
• Status: Completed
• Phase: N/A
• First received: March 10, 2009
• Last updated: March 10, 2009
• Start date: July 2006
• Est. completion date: July 2007

Study information

• Verified date: March 2009
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• relapsing remitting MS

• indication for natalizumab treatment

Exclusion Criteria:

• other disease modifying agents within 2 weeks

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing Remitting
• Multiple Sclerosis, Relapsing-Remitting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function of T regulatory cells		at month 3	No
Secondary	Change in distinct immune cell lines		month 3	No