Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells

NCT ID: NCT00630721

Last Updated: 2018-10-18

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

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-03-15

Brief Summary

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Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the expression of SOCS3 in DCs.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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IFNbeta-1b

no drug was given under study. patients already taking IFNbeta-1b were enrolled for blood draw only.

Group Type OTHER

IFNbeta-1b

Intervention Type OTHER

no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.

Interventions

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IFNbeta-1b

no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of MS
* Age 18-60 years, inclusive
* Expanded disability status of 0-6.5
* Give written informed consent prior to any testing under this protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silva Markovic-Plese, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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07-0941

Identifier Type: -

Identifier Source: org_study_id

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