Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Interferon beta, plasmacytoid dendritic cells
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.
Interventions
DRUGInterferon-beta 1b (Betaseron)
Treatment of patients with FDA-approved Rx
Sponsors
Bayer
Rutgers, The State University of New Jersey
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative gene expression in plasmacytoid dendritic cells (pDCs) | 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 |
Countries
United States
Outcome results
None listed