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, June 2009

First Received: February 28, 2008 Last Updated: June 23, 2009 History of Changes

Sponsor:	The University of North Carolina, Chapel Hill
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

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Interferon beta-1b Interferons

U.S. FDA Resources

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

The University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Silva Markovic-Plese, MD

UNC Chapel Hill

More Information

No publications provided

Responsible Party:	University of North Carolina at Chapel Hill ( Silva Markovic-Plese, MD/Principal Investigator )
Study ID Numbers:	07-0941
Study First Received:	February 28, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00630721 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Infective Agents
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Interferons
Adjuvants, Immunologic

Interferon-beta
Sclerosis
Antiviral Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on February 08, 2010