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

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

This study is currently recruiting participants.
Verified by The University of North Carolina, Chapel Hill, February 2008

Sponsored by:	University of North Carolina
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00630721

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: INFNb-1b	Phase I

MedlinePlus related topics:

Multiple Sclerosis

Drug Information available for:

Interferon alfa-2b Interferons Interferon beta Interferon-beta Interferon beta-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Dose Comparison, Single Group Assignment

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

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Characterize the effect of IFN-1b-induced SOCS3 expression in DCs on Th1/Th2 cell differentiation and T-cell cytokine transcription. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

drug

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630721

Contacts


Contact: Silva Markovic-Plese, MD	919-966-5547	markovics@neurology.unc.edu

Locations


United States, North Carolina
	University of North Carolina	Recruiting
	Chapel Hill, North Carolina, United States, 27599
	Contact: Liseanne Fedor-Hammonds, BS 919-843-7857 hammondsl@neurology.unc.edu

Sponsors and Collaborators

University of North Carolina

Investigators


Principal Investigator:	Silva Markovic-Plese, MD	UNC Chapel Hill

More Information

Responsible Party:	University of North Carolina at Chapel Hill ( Silva Markovic-Plese, MD/Principal Investigator )
Study ID Numbers:	07-0941
First Received:	February 28, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00630721
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Interferons

Interferon beta-1b

Interferon-beta

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Interferon Alfa-2b

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Infective Agents

Pathologic Processes

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Adjuvants, Immunologic

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008