Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468182
• Other study ID #: 0220060228
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2007
• Last updated: May 5, 2015
• Start date: April 2007
• Est. completion date: December 2011

Study information

• Verified date: May 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon-beta 1b (Betaseron)
Treatment of patients with FDA-approved Rx

Locations

Country	Name	City	State
United States	Rutgers-RWJMS	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Bayer

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 — View Citation

Balashov KE, Aung LL, Vaknin-Dembinsky A, Dhib-Jalbut S, Weiner HL. Interferon-ß inhibits toll-like receptor 9 processing in multiple sclerosis. Ann Neurol. 2010 Dec;68(6):899-906. doi: 10.1002/ana.22136. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative gene expression in plasmacytoid dendritic cells (pDCs)	Gene expression is tested in pDCs separetd from peripheral blood of human subjects at baseline and at 12 weeks	Change in gene expression in 12 weeks	No