Differential Immune Effects of Natalizumab

NCT ID: NCT00859482

Last Updated: 2009-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-07-31

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).

Conditions

Multiple Sclerosis, Relapsing Remitting

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• relapsing remitting MS
• indication for natalizumab treatment

Exclusion Criteria

• other disease modifying agents within 2 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Cantonal Hospital St. Gallen

Principal Investigators

Norman Putzki, MD

Role: PRINCIPAL_INVESTIGATOR

KSSG, 9007 St. Gallen, Switzerland

Other Identifiers

Ntz-Tregs1

Identifier Type: -

Identifier Source: org_study_id