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Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, June 2008
Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
Bayer
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00468182
  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 IV

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferons Interferon beta Interferon-beta Interferon beta-1b
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

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

Estimated Enrollment: 24
Study Start Date: April 2007
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

Contacts
Contact: Konstantin Balashov, M.D., Ph.D. 732-235-7340 balashke@umdnj.edu

Locations
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Konstantin Balashov, M.D., Ph.D.     732-235-7732     balashke@umdnj.edu    
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

Responsible Party: UMDNJ ( Konstantin Balashov, MD, PhD )
Study ID Numbers: 0220060228
Study First Received: April 30, 2007
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00468182  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta-1b
Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009