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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: IFNbeta-1b

• Registration Number: NCT00630721
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Primary Completion: 2010-05-15
• Study Completion: 2011-03-15
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IFNbeta-1b	IFNbeta-1b	no drug was given under study. patients already taking IFNbeta-1b were enrolled for blood draw only.

Primary Outcome Measures

Name	Time	Method
Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present	2 years

Secondary Outcome Measures

Name	Time	Method
Characterize the effect of IFN-1b-induced SOCS3 expression in DCs on Th1/Th2 cell differentiation and T-cell cytokine transcription.	2 years

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States