NCT00630721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2011

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

February 28, 2008

Last Update Submit

October 16, 2018

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (1)

IFNbeta-1b

OTHER

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

Other: IFNbeta-1b

Interventions

IFNbeta-1bOTHER

no drug was given under study arm. only blood draw on patients already on IFNbeta-1b.

IFNbeta-1b

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Silva Markovic-Plese, MD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

September 1, 2007

Primary Completion

May 15, 2010

Study Completion

March 15, 2011

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

US(1)