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

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.

Completed

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Infliximab

Drug

Other names: Remicade

Primary outcomes

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

Time frame: 1-year treatment period

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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Aug 9, 2012
Registry last updated: Aug 9, 2012

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.

Published trials that share one or more normalized conditions with this study.

Completed