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Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

This study has been completed.
Information provided by (Responsible Party):
Konstantin Balashov, Rutgers, The State University of New Jersey Identifier:
First received: April 30, 2007
Last updated: May 5, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Multiple Sclerosis
Drug: Interferon-beta 1b (Betaseron)
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Relative gene expression in plasmacytoid dendritic cells (pDCs) [ Time Frame: Change in gene expression in 12 weeks ]
    Gene expression is tested in pDCs separetd from peripheral blood of human subjects at baseline and at 12 weeks

Enrollment: 24
Study Start Date: April 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Treatment of patients with FDA-approved Rx
MS patients or patients with CIS(Clinically isolated syndrome)who decided to postpone the treatment with IFN-beta


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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
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Please refer to this study by its identifier: NCT00468182

United States, New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Principal Investigator: Konstantin Balashov, M.D., Ph.D. Rutgers-Robert Wood Johnson Medical School
  More Information

Responsible Party: Konstantin Balashov, Associate Professor, Rutgers, The State University of New Jersey Identifier: NCT00468182     History of Changes
Other Study ID Numbers: 0220060228
Study First Received: April 30, 2007
Last Updated: May 5, 2015

Keywords provided by Rutgers, The State University of New Jersey:
Multiple sclerosis
Interferon beta
plasmacytoid dendritic cells

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on April 27, 2017