Clinical trial NCT00468182: Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
Official title: Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Interferon beta
plasmacytoid dendritic cells
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis Clinic patient

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.


Eligibility 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

Primary outcomes:
measure: Relative gene expression in plasmacytoid dendritic cells (pDCs)
timeFrame: Change in gene expression in 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers-RWJMS
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Konstantin Balashov, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aung LL, Brooks A, Greenberg SA, Rosenberg ML, Dhib-Jalbut S, Balashov KE. Multiple sclerosis-linked and interferon-beta-regulated gene expression in plasmacytoid dendritic cells. J Neuroimmunol. 2012 Sep 15;250(1-2):99-105. doi: 10.1016/j.jneuroim.2012.05.013. Epub 2012 Jun 9.
citation: Balashov KE, Aung LL, Vaknin-Dembinsky A, Dhib-Jalbut S, Weiner HL. Interferon-beta inhibits toll-like receptor 9 processing in multiple sclerosis. Ann Neurol. 2010 Dec;68(6):899-906. doi: 10.1002/ana.22136.
citation: Aung LL, Fitzgerald-Bocarsly P, Dhib-Jalbut S, Balashov K. Plasmacytoid dendritic cells in multiple sclerosis: chemokine and chemokine receptor modulation by interferon-beta. J Neuroimmunol. 2010 Sep 14;226(1-2):158-64. doi: 10.1016/j.jneuroim.2010.06.008.