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

Phase 3
Completed
Conditions
Crohn's Disease
Interventions
Registration Number
NCT01661257
Lead Sponsor
Samsung Medical Center
Brief Summary

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

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TIM-3InfliximabT-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.
Primary Outcome Measures
NameTimeMethod
Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-α Therapy1-year treatment period

Disease Activity Index (PCDAI) scores, Peripheral blood for TIM-3 mRNA expression

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

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