Characterization of Interferon Beta -1b-Induced Tolerizin... | NCT00630721

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

NCT00630721

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Oct 18, 2018Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

IFNbeta-1b

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

May 15, 2010Actual

Completion Date

Mar 15, 2011Actual

First Submitted Date

Feb 28, 2008

First Submission Date that Met QC Criteria

Mar 6, 2008

First Posted Date

Mar 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2018

Last Update Posted Date

Oct 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IFNbeta-1b	Other	no drug was given under study. patients already taking IFNbeta-1b were enrolled for blood draw only.	Other: IFNbeta-1b

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IFNbeta-1b	Other	no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.	IFNbeta-1b

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Silva Markovic-Plese, MD	UNC Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina		Chapel Hill	North Carolina	27599	United States

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided