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OpenTrials
Completed

NCT Number: NCT00630721

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IFNbeta-1b

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Mar 7, 2008
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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