Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon-beta 1b (Betaseron)

• Registration Number: NCT00468182
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-30
• Study First Submitted QC: 2007-04-30
• Study First Posted: 2007-05-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Interferon-beta 1b (Betaseron)	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rutgers-RWJMS; 🇺🇸 New Brunswick, New Jersey, United States