NCT00468182CompletedNot Applicable
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
Rutgers, The State University of New Jersey1 site in 1 country24 target enrollmentStarted: April 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Relative gene expression in plasmacytoid dendritic cells (pDCs)
Study Overview
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & 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)
Intervention: Interferon-beta 1b (Betaseron) (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Konstantin Balashov
Associate Professor
Rutgers, The State University of New Jersey
Study Sites (1)
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