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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02847884
Date of registration: 30/11/2015
Prospective Registration: Yes
Primary sponsor: University of Alberta
Public title: IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study IDeaL
Scientific title: IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study
Date of first enrolment: October 2015
Target sample size: 28
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02847884
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Canada
Contacts
Name:     Hien Q Huynh, MD
Address: 
Telephone:
Email:
Affiliation:  University of Alberta
Key inclusion & exclusion criteria

Inclusion Criteria:

- A signed informed consent form by the participant's parent or legal guardian, where
applicable assent from the participant must also be obtained.

- Aged 2 to 17 years of age

- Known diagnosis of Crohn's Disease.

- IFX initiated as clinically indicated.

- Concurrent use of immunomodulators allowed.

- Endoscopy and/OR imaging depending on disease areas in the GI tract last 3 months
(Paris classification/Simple Endoscopic Score - SES-CD).

Exclusion Criteria:

• Past exposure to anti-TNF therapy



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Disease
Intervention(s)
Biological: Infliximab
Primary Outcome(s)
The proportion of children with IFX trough level with the range of 5 to 10 µg/ml [Time Frame: at Week 10]
Secondary Outcome(s)
Proportion in clinical remission and symptom response using the pediatric Crohn's disease activity index (PCDAI) [Time Frame: Beginning of the maintenance dose at the 5th dose of treatment/week 22]
The proportion of children with IFX trough level within the range of 5 to 10 µg/ml [Time Frame: at week 14]
Secondary ID(s)
Pro00056259
UAlberta
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Alberta Children's Hospital
Children's Hospital of Eastern Ontario
Provincial Health Services Authority
The Children's Hospital of Winnipeg
The Hospital for Sick Children
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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