IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study (IDeaL)
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|ClinicalTrials.gov Identifier: NCT02847884|
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : May 31, 2019
Crohn's disease (CD) is a lifelong condition of inflammation in the bowel. CD can affect any part of the gastrointestinal tract from mouth to anus. Symptoms can include: tiredness, stomach pain, diarrhea (which may be bloody if the disease is severe), fever, weight loss, skin rashes, arthritis and inflammation of the eye.
Infliximab-IFX (Remicade®) is a medication that is used to treat CD in adults and children. In adults it has been shown that the amount of this drug a person has in their blood can show how well it is working for them. Health Canada has approved Infliximab -IFX for the treatment of CD in children 9 and older. In Canada, doctors may prescribe Inflixmab to younger children when other therapies do not resolve their disease symptoms. This is called "off-label" use of Infliximab.
IFX levels in the body and consequently its efficacy can be influenced by many biological characteristics within the patient's body. In about 17% of those treated with IFX, the patient's immune response against IFX may lead to a three to fivefold increased risk of loss of response. This immune response to the medication often occurs when drug levels are undetectable in the body. Thus it is in order to achieve best results with this treatment, physicians need to be able to adjust dosing specific to each patient. A recent study has shown that 29% of children have an undetectable IFX level at the 4th medication infusion. Up to 40% of patients receiving scheduled IFX have undetectable drug level prior to their next infusion.
In order to minimize the loss of response, we hope to conduct an observational cohort study of pediatric patients treated with IFX.
This open label, cohort study aims to:
- Determine the pharmacokinetics of IFX in children with CD and the factors that affect IFX levels during the first three loading infusions
- Obtain data to create a model that can guide and adjust the IFX dose and frequency to achieve optimal trough level between 5 and 10 ug /ml at 14 weeks.
|Condition or disease||Intervention/treatment|
|Inflammatory Bowel Disease Crohn's Disease||Biological: Infliximab|
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||June 2018|
- Biological: Infliximab
Patients will be prescribed Infliximab as a standard of care regardless of study participation.Other Name: Remicade
- The proportion of children with IFX trough level with the range of 5 to 10 µg/ml [ Time Frame: at Week 10 ]
- The proportion of children with IFX trough level within the range of 5 to 10 µg/ml [ Time Frame: at week 14 ]however, participants are being treated as per standard of care. It may be possible that the dose may be administered early as deemed necessary by treating provider.
- 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 ]This level will be measured prior to the 5th dose. Ideally, this will done at week 22; however, participants are being treated as per standard of care. It may be possible that the dose may be administered early as deemed necessary by treating provider.
Biospecimen Retention: Samples Without DNA
Blood will be collected to determine IFX levels and serum cytokines. Stool will be collected for calprotectin. Urine will be collected for metabolomics.
If a child undergoes endoscopy or surgery during the 8 weeks after beginning IFX, a specimen will be collected for tissue cytokine assay.
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): NCT02847884
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Hien Q Huynh, MD||University of Alberta|