Differential Immune Effects of Natalizumab - Full Text View

Sponsored by:	Cantonal Hospital of St. Gallen
Information provided by:	Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00859482

Purpose

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.

Condition
Multiple Sclerosis, Relapsing Remitting

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Phase IV Study to Investigate Differential Immune Effects of Natalizumab

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:

Function of T regulatory cells [ Time Frame: at month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in distinct immune cell lines [ Time Frame: month 3 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

full blodd

Enrollment:	27
Study Start Date:	July 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients initiating natalizumab for treatment of relapsing remitting MS

Criteria

Inclusion Criteria:

relapsing remitting MS
indication for natalizumab treatment

Exclusion Criteria:

other disease modifying agents within 2 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859482

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

Investigators

Principal Investigator:

Norman Putzki, MD

KSSG, 9007 St. Gallen, Switzerland

More Information

No publications provided

Responsible Party:	Cantonal Hospital St. Gallen ( Norman Putzki, MD )
Study ID Numbers:	Ntz-Tregs1
Study First Received:	March 10, 2009
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00859482 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by Cantonal Hospital of St. Gallen:

natalizumab
multiple sclerosis

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

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

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

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

ClinicalTrials.gov processed this record on September 11, 2009