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Trial record 12 of 166 for:    PEMT

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

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ClinicalTrials.gov Identifier: NCT01661257
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : August 9, 2012
Sponsor:
Information provided by (Responsible Party):
YonHo Choe, 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Infliximab Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: TIM-3
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.
Drug: Infliximab
Other Name: Remicade




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661257


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: YonHo Choe, Pediatrics, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01661257     History of Changes
Other Study ID Numbers: 2009-10-038-002
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012
Keywords provided by YonHo Choe, Samsung Medical Center:
Crohn's disease
Infliximab
T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Immunoglobulins
Antibodies
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs