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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silva Markovic-Plese, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00630721
First received: February 28, 2008
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  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
 Other: IFNbeta-1b
 Phase 1

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:

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 ]

Enrollment: 56
Study Start Date: September 2007
Study Completion Date: March 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IFNbeta-1b
no drug was given under study. patients already taking IFNbeta-1b were enrolled for blood draw only.
 Other: IFNbeta-1b
no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.

  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

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
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, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00630721     History of Changes
Other Study ID Numbers: 07-0941
Study First Received: February 28, 2008
Last Updated: April 2, 2013
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 May 19, 2013