Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

May 5, 2015 updated by: Konstantin Balashov, Rutgers, The State University of New Jersey
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers-Rwjms

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple Sclerosis Clinic patient

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Drug: Interferon-beta 1b (Betaseron)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in gene expression in 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

Bayer

Investigators

  • Principal Investigator: Konstantin Balashov, M.D., Ph.D., Rutgers Robert Wood Johnson Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

April 30, 2007

First Posted (Estimate)

May 2, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0220060228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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