Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study (IDeaL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02847884
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
The Hospital for Sick Children
The Children's Hospital of Winnipeg
Alberta Children's Hospital
Provincial Health Services Authority
Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

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:

  1. Determine the pharmacokinetics of IFX in children with CD and the factors that affect IFX levels during the first three loading infusions
  2. 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

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

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


Intervention Details:
  • Biological: Infliximab
    Patients will be prescribed Infliximab as a standard of care regardless of study participation.
    Other Name: Remicade


Primary Outcome Measures :
  1. The proportion of children with IFX trough level with the range of 5 to 10 µg/ml [ Time Frame: at Week 10 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with Crohn's Disease whose treating physician has planned to start IFX for treatment of their CD.
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


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): NCT02847884


Locations
Layout table for location information
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada
Canada, Ontario
SickKids
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
University of Alberta
The Hospital for Sick Children
The Children's Hospital of Winnipeg
Alberta Children's Hospital
Provincial Health Services Authority
Children's Hospital of Eastern Ontario
Investigators
Layout table for investigator information
Principal Investigator: Hien Q Huynh, MD University of Alberta
Additional Information:
Publications:
Lamblin, C, Auburg,A, Ternant, D, Picon,L, Lecomte, T, and Paintaud, G. Concentration effect relationship of infliximab in Crohn's disease: Results of a cohort study. Journal of Crohn's and Colitis 2012; 6: S142-S143.
Arias, MT, Vande, CN, Drobne, D et al. Importance of trough levels and antibodies on the long-term efficacy of infliximab therapy in ulcerative colitis. Journal of Crohn's and Colitis 2012; 6: s5.

Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02847884    
Other Study ID Numbers: UAlberta
Pro00056259 ( Other Identifier: University of Alberta HREB Number )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Alberta:
IBD
Crohn's disease
Remicade
Infliximab
Level
Drug Level
Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents