World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
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: EUCTR
Last refreshed on: 8 January 2024
Main ID:  EUCTR2022-002648-35-NL
Date of registration: 22/11/2022
Prospective Registration: Yes
Primary sponsor: Erasmus Medical Center
Public title: Prospective Analysis of Pharmacokinetic Infliximab Data in pediatric CD patients
Scientific title: Prospective Analysis of Pharmacokinetic Infliximab Data in pediatric CD patients - PRO-RAPID
Date of first enrolment: 04/01/2023
Target sample size: 50
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2022-002648-35
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Italy Netherlands
Contacts
Name: Principal investigator   
Address:  Dr. Molewaterplein 40 3015 GD Rotterdam Netherlands
Telephone:
Email: l.deridder@erasmusmc.nl
Affiliation:  Erasmus Medical Center
Name: Principal investigator   
Address:  Dr. Molewaterplein 40 3015 GD Rotterdam Netherlands
Telephone:
Email: l.deridder@erasmusmc.nl
Affiliation:  Erasmus Medical Center
Key inclusion & exclusion criteria
Inclusion criteria:
Anti-TNF-a naïve children (age 1-15 years) with CD and an indication to
start IFX treatment will be eligible for inclusion after a diagnosis of CD is
made based on the Porto criteria [11]. Indications of starting IFX
treatment as per ECCO-ESPGHAN guidelines include non-response after
induction with exclusive enteral nutrition or steroids, non-response to
immunomodulators, severe growth delay, extensive disease and/or
structuring or penetrating disease, with or without perianal disease.
Evaluation of the indication to start IFX is performed at the discretion of
the attending physician.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients with the following characteristics will be excluded:
- Established monogenetic IBD
- Diagnosis with UC or IBD-U, ulcerative colitis like
- Active fistulizing/perianal disease at start of IFX treatment (patients with inactive fistulizing/perianal disease are allowed to participate)
- Severe comorbidity (not related to IBD)
- Immediate need for surgery (i.e., symptomatic stenosis or stricture in the bowel)
- Severe infection such as sepsis or opportunistic infections, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy
- Pregnancy, suspected or definitive
- Treatment with anti-TNF or other biological drugs in the past
- Start of corticosteroids or mesalazine less than 2 weeks prior to first IFX infusion
- Start of Exclusive Enteral Nutrition less than 2 week prior to first IFX infusion


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Crohn's disease
Intervention(s)

Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion

Primary Outcome(s)
Main Objective: The primary study objective of our study is to assess the efficacy of an
IFX intensified induction scheme vs. a standard dosing schedule in
improving drug exposure (=therapeutic trough levels) without treatment
escalation in pediatric CD patients.
Primary end point(s): Proportion of patients with IFX TL = 5 µg/mL at week 12 without
treatment escalation.
Secondary Objective: • Proportion of patients with IFX TL = 5 µg/mL at week 24 without the
need for treatment escalation
• Clinical and biochemical remission at weeks 4, 12, and 24 without the
need for treatment escalation in patients with TL = 5 µg/mL and in
patients with TL < 5 µg/mL
• Predictors of IFX TLs at weeks 4, 12, and 24. Factors included in this
analysis will be sex, age, body mass index (BMI), wPCDAI, IBD
laboratory values, ATI, dose, and interval of IFX infusions
• Development of ATI until week 24
• Prediction of patients who will respond vs. those who will not despite
adequate TLs at weeks 12 and 24 based on proteomics analysis by
OLINK
• Evaluation of quality of life at baseline, weeks 4, 12, and 24 in all
patients
• Adverse event rate over time
Timepoint(s) of evaluation of this end point: 12 weeks
Secondary Outcome(s)
Secondary end point(s): • Proportion of patients with IFX TL = 5 µg/mL at week 24 without the
need for treatment escalation
• Clinical and biochemical remission at weeks 4, 12, and 24 without the
need for treatment escalation in patients with TL = 5 µg/mL and in
patients with TL < 5 µg/mL
• Predictors of IFX TLs at weeks 4, 12, and 24. Factors included in this
analysis will be sex, age, body mass index (BMI), wPCDAI, IBD
laboratory values, ATI, dose, and interval of IFX infusions
• Development of ATI until week 24
• Prediction of patients who will respond vs. those who will not despite
adequate TLs at weeks 12 and 24 based on proteomics analysis by
OLINK
• Evaluation of quality of life at baseline, weeks 4, 12, and 24 in all
patients
• Adverse event rate over time
Timepoint(s) of evaluation of this end point: See within description of secondary endpoints
Secondary ID(s)
ProRAPID
Source(s) of Monetary Support
Erasmus MC
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 04/01/2023
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey