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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01661257
• Date of registration: 07/08/2012
• Prospective Registration: No
• Primary sponsor: Samsung Medical Center
• Public title: Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy
• Scientific 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-a Therapy
• Date of first enrolment: October 2009
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01661257
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

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



Age minimum: 13 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Infliximab

Primary Outcome(s)

Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-a Therapy [Time Frame: 1-year treatment period]

Secondary ID(s)

2009-10-038-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors