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Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468182
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : May 7, 2015
Information provided by (Responsible Party):
Konstantin Balashov, Rutgers, The State University of New Jersey

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon-beta 1b (Betaseron)

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Study Type : Observational
Actual Enrollment : 24 participants
Time Perspective: Prospective
Official Title: Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
Study Start Date : April 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468182

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United States, New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
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Principal Investigator: Konstantin Balashov, M.D., Ph.D. Rutgers Robert Wood Johnson Medical School
Publications of Results:
Other Publications:
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Responsible Party: Konstantin Balashov, Associate Professor, Rutgers, The State University of New Jersey Identifier: NCT00468182    
Other Study ID Numbers: 0220060228
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015
Keywords provided by Konstantin Balashov, Rutgers, The State University of New Jersey:
Multiple sclerosis
Interferon beta
plasmacytoid dendritic cells
Additional relevant MeSH terms:
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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