Back to resultsExpression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional basic science trial for Crohn's Disease focused on measuring Crohn's disease, Infliximab, T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)
Eligibility 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TIM-3
Arm Description
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.
Outcomes
Primary Outcome Measures
Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-α Therapy
Disease Activity Index (PCDAI) scores, Peripheral blood for TIM-3 mRNA expression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01661257
Brief Title
Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Infliximab, T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TIM-3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade
Primary Outcome Measure Information:
Title
Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-α Therapy
Description
Disease Activity Index (PCDAI) scores, Peripheral blood for TIM-3 mRNA expression
Time Frame
1-year treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy
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