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Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
kbalashov, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00468182
First received: April 30, 2007
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Relative gene expression in plasmacytoid dendritic cells (pDCs) [ Time Frame: Change in gene expression in 12 weeks ] [ Designated as safety issue: No ]
    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
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468182

Locations
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Bayer
Investigators
Principal Investigator: Konstantin Balashov, M.D., Ph.D. University of Medicine and Dentistry New Jersey
  More Information

Publications:

Responsible Party: kbalashov, Associate Professor, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00468182     History of Changes
Other Study ID Numbers: 0220060228
Study First Received: April 30, 2007
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Multiple sclerosis
Interferon beta
plasmacytoid dendritic cells

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 16, 2013