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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02847884 |
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Date of registration:
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30/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study
IDeaL |
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Scientific title:
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IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02847884 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Hien Q Huynh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Inflammatory Bowel Disease
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Intervention(s)
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Biological: Infliximab
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Primary Outcome(s)
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The proportion of children with IFX trough level with the range of 5 to 10 µg/ml
[Time Frame: at Week 10]
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Secondary Outcome(s)
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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]
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The proportion of children with IFX trough level within the range of 5 to 10 µg/ml
[Time Frame: at week 14]
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Secondary ID(s)
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UAlberta
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Pro00056259
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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