NCT01661257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

1.7 years

First QC Date

August 7, 2012

Last Update Submit

August 7, 2012

Conditions

Crohn's Disease

Keywords

Crohn's diseaseInfliximabT-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)

Outcome Measures

Primary Outcomes (1)

  • 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

    1-year treatment period

Study Arms (1)

TIM-3

EXPERIMENTAL

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

Interventions

InfliximabDRUG
Also known as: Remicade
TIM-3

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • patients who has proven to have infliximab antibody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrics

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

October 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

KR(1)