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Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00468182
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : May 7, 2015
Sponsor:
Collaborator:
Bayer
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)

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
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)
Treatment of patients with FDA-approved Rx

2
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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00468182


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

Publications of Results:
Other Publications:
Responsible Party: Konstantin Balashov, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00468182     History of Changes
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:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic