Skip to main content
OpenTrials
Completed

NCT Number: NCT00468182

Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rutgers-RWJMS

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon-beta 1b (Betaseron)

Drug

Treatment of patients with FDA-approved Rx

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 2, 2007
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.