Back to resultsCharacterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IFNbeta-1b
Sponsored by
About this trial
This is an interventional basic science trial for Multiple Sclerosis
Eligibility 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
Sites / Locations
- University of North Carolina
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
IFNbeta-1b
Arm Description
no drug was given under study. patients already taking IFNbeta-1b were enrolled for blood draw only.
Outcomes
Primary Outcome Measures
Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present
Secondary Outcome Measures
Characterize the effect of IFN-1b-induced SOCS3 expression in DCs on Th1/Th2 cell differentiation and T-cell cytokine transcription.
Full Information
NCT ID
NCT00630721
First Posted
February 28, 2008
Last Updated
October 16, 2018
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00630721
Brief Title
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
Official Title
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 15, 2010 (Actual)
Study Completion Date
March 15, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IFNbeta-1b
Arm Type
Other
Arm Description
no drug was given under study. patients already taking IFNbeta-1b were enrolled for blood draw only.
Intervention Type
Other
Intervention Name(s)
IFNbeta-1b
Intervention Description
no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silva Markovic-Plese, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
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