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CompletedNCT00468182Updated May 7, 2015

Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-05-07.

Sponsored by Rutgers, The State University of New Jersey · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
24
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.

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Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple sclerosis
  • Interferon beta
  • plasmacytoid dendritic cells
03

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 24 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Multiple Sclerosis Clinic patient

Inclusion criteria

  • Males and females, 18 to 60 year old, inclusive.
  • Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria
  • Expanded disability status scale (EDSS) score less than 6 at entry.
  • Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

Exclusion criteria

Exclusion Criteria:

  • Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study.
  • No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies
  • Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
  • History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy.
  • Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years
05

Study design

Time perspective
Prospective
Enrollment
24 participants (actual)

Groups and cohorts

  • 1

    MS patients or patients with CIS (Clinically isolated syndrome) who decided to be treated with IFN-beta for 3 months (with the option to continue Rx)

    Drug: Interferon-beta 1b (Betaseron)

  • 2

    MS patients or patients with CIS(Clinically isolated syndrome)who decided to postpone the treatment with IFN-beta

Interventions

  • DrugInterferon-beta 1b (Betaseron)

    Treatment of patients with FDA-approved Rx

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What researchers measure

Primary outcomes

  1. Relative gene expression in plasmacytoid dendritic cells (pDCs)

    Gene expression is tested in pDCs separetd from peripheral blood of human subjects at baseline and at 12 weeks

    Time frame: Change in gene expression in 12 weeks

07

Study locations

1 site
  • Rutgers-RWJMS
    New Brunswick, New Jersey 08901, United States
08

References and documents

Publications

  • Aung LL, Brooks A, Greenberg SA, Rosenberg ML, Dhib-Jalbut S, Balashov KE. Multiple sclerosis-linked and interferon-beta-regulated gene expression in plasmacytoid dendritic cells. J Neuroimmunol. 2012 Sep 15;250(1-2):99-105. doi: 10.1016/j.jneuroim.2012.05.013. Epub 2012 Jun 9. PubMed 22688425 ↗
  • Balashov KE, Aung LL, Vaknin-Dembinsky A, Dhib-Jalbut S, Weiner HL. Interferon-beta inhibits toll-like receptor 9 processing in multiple sclerosis. Ann Neurol. 2010 Dec;68(6):899-906. doi: 10.1002/ana.22136. PubMed 21061396 ↗
  • Aung LL, Fitzgerald-Bocarsly P, Dhib-Jalbut S, Balashov K. Plasmacytoid dendritic cells in multiple sclerosis: chemokine and chemokine receptor modulation by interferon-beta. J Neuroimmunol. 2010 Sep 14;226(1-2):158-64. doi: 10.1016/j.jneuroim.2010.06.008. PubMed 20621365 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2015, 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
NCT00468182
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
Bayer
Responsible party
Konstantin Balashov (Associate Professor, Rutgers, The State University of New Jersey) — Principal investigator
First posted
May 2, 2007
Start date
Apr 2007
Primary completion
Dec 2011
Completion
Dec 2011
Last update
May 7, 2015

Study contacts

Konstantin Balashov, M.D., Ph.D.
principal investigator · Rutgers Robert Wood Johnson Medical School

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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