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
  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:


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 ] [ 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
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, see Learn About Clinical Studies.

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 of New Jersey
Bayer
Investigators
Principal Investigator: Konstantin Balashov, M.D., Ph.D. Rutgers, The State University of 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 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
Interferon-beta
Interferons
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on October 19, 2014