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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630721
First Posted: March 7, 2008
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Silva Markovic-Plese, MD, University of North Carolina, Chapel Hill
  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: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells

Resource links provided by NLM:


Further study details as provided by Silva Markovic-Plese, MD, 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 ]

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 ]

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

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 28, 2008
First Posted: March 7, 2008
Last Update Posted: April 4, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs