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NCT01661257 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
Expression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01661257
Other study ID # 2009-10-038-002
Secondary ID
Status Completed
Phase Phase 3
First received August 7, 2012
Last updated August 7, 2012
Start date October 2009
Est. completion date June 2011

Study information
Verified date August 2012
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 17 Years
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Infliximab

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-a Therapy Disease Activity Index (PCDAI) scores, Peripheral blood for TIM-3 mRNA expression 1-year treatment period No
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