Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Interferon-beta 1b (Betaseron)

Intervention Type DRUG

Treatment of patients with FDA-approved Rx

2

MS patients or patients with CIS(Clinically isolated syndrome)who decided to postpone the treatment with IFN-beta

No interventions assigned to this group

Interventions

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Interferon-beta 1b (Betaseron)

Treatment of patients with FDA-approved Rx

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No