Prospective Analysis of Pharmacokinetic Infliximab Data in pediatric CDpatients

Phase 1

Active, not recruiting

• Conditions: Crohn's disease; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2022-002648-35-NL
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-22
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified