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Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy

NCT ID: NCT01661257

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-06-30

Brief Summary

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This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's disease during anti TNF-α (infliximab) therapy.

Detailed Description

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The immunoregulatory effects of TIM-3 on patients with Crohn's disease according to the treatment have not yet been investigated.

Conditions

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Crohn's Disease

Keywords

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Crohn's disease Infliximab T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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TIM-3

T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3) is a novel transmembrane protein that is involved in the regulation of Th1-cell-mediated immunity.

Group Type EXPERIMENTAL

Infliximab

Intervention Type DRUG

Interventions

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Infliximab

Intervention Type DRUG

Other Intervention Names

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Remicade

Eligibility Criteria

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Inclusion Criteria

* •Pediatric patients who were diagnosed with severe Crohn's disease who require infliximab treatment

* confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological findings

Exclusion Criteria

* •patients who has proven to have infliximab antibody
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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YonHo Choe

Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2009-10-038-002

Identifier Type: -

Identifier Source: org_study_id