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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by University of North Carolina, Chapel Hill. Recruitment status was Recruiting

First Received on February 28, 2008. Last Updated on February 24, 2010 History of Changes

Sponsor:	University of North Carolina, Chapel Hill
Information provided by:	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:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
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 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 Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (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: Manisha Chopra

(919) 843-7857

chopram@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, Chapel Hill

Investigators

Principal Investigator:

Silva Markovic-Plese, MD

UNC Chapel Hill

More Information

No publications provided

Responsible Party:	Silva Markovic-Plese, MD/Principal Investigator, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier:	NCT00630721 History of Changes
Other Study ID Numbers:	07-0941
Study First Received:	February 28, 2008
Last Updated:	February 24, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta

Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012