NCT00468182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

4.7 years

First QC Date

April 30, 2007

Last Update Submit

May 5, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisInterferon betaplasmacytoid dendritic cells

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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)

2

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

Interventions

Interferon-beta 1b (Betaseron)DRUG

Treatment of patients with FDA-approved Rx

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Multiple Sclerosis Clinic patient

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers-RWJMS

New Brunswick, New Jersey, 08901, United States

Location

Related 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.

    PMID: 22688425BACKGROUND

  • 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.

    PMID: 21061396RESULT

  • 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.

    PMID: 20621365RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Konstantin Balashov, M.D., Ph.D.

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

US(1)