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CompletedNCT00859482Updated Mar 11, 2009

Differential Immune Effects of Natalizumab

An observational study in Multiple Sclerosis, Relapsing Remitting, sponsored by Cantonal Hospital of St. Gallen. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-03-11.

Sponsored by Cantonal Hospital of St. Gallen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
27
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Multiple Sclerosis, Relapsing Remitting

Keywords

  • natalizumab
  • multiple sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 27 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients initiating natalizumab for treatment of relapsing remitting MS

Inclusion criteria

  • relapsing remitting MS
  • indication for natalizumab treatment

Exclusion criteria

Exclusion Criteria:

  • other disease modifying agents within 2 weeks
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
27 participants (actual)
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Function of T regulatory cells

    Time frame: at month 3

Secondary outcomes

  1. Change in distinct immune cell lines

    Time frame: month 3

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00859482
Lead sponsor
Cantonal Hospital of St. Gallen
First posted
Mar 11, 2009
Start date
Jul 2006
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Mar 11, 2009

Study contacts

Norman Putzki, MD
principal investigator · KSSG, 9007 St. Gallen, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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