Pro-RAPID

Phase 4

Not yet recruiting

• Conditions: Crohn's Disease

• Registration Number: 2023-507352-72-00
• Lead Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Brief Summary

To assess the proportion of patients with IFX trough level ≥ 5 µg/mL at week 12 without treatment escalation

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-05-23
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Anti-TNF-α naïve children (age 1-15 years) with CD or IBD-U and an indication to start IFX treatment will be eligible for inclusion after a diagnosis of CD is made based on the Porto criteria [10]. Indications of starting IFX treatment as per ECCO-ESPGHAN guidelines [9] 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.

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

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the proportion of patients with IFX TL ≥ 5 µg/mL at week 12 without treatment escalation.		The primary endpoint is the proportion of patients with IFX TL ≥ 5 µg/mL at week 12 without treatment escalation.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with IFX TL ≥ 5 µg/mL at week 24 without the need for treatment escalation,proportion of patients in clinical and/or biochemical remission at weeks 4, 12, and week 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		Proportion of patients with IFX TL ≥ 5 µg/mL at week 24 without the need for treatment escalation,proportion of patients in clinical and/or biochemical remission at weeks 4, 12, and week 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

Trial Locations

Locations (10)

Amphia Hospital; 🇳🇱 Breda, Netherlands

Sint Antonius Ziekenhuis Stichting; 🇳🇱 Nieuwegein, Netherlands

Amsterdam UMC Stichting; 🇳🇱 Amsterdam, Netherlands

Rijnstate Ziekenhuis Stichting; 🇳🇱 Arnhem, Netherlands

Sint Franciscus Vlietland Groep Stichting; 🇳🇱 Rotterdam, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC); 🇳🇱 Rotterdam, Netherlands

Maasstad Ziekenhuis Stichting; 🇳🇱 Rotterdam, Netherlands

Isala Klinieken Stichting; 🇳🇱 Zwolle, Netherlands

Wilhelmina Childrens Hospital; 🇳🇱 Utrecht, Netherlands

Catharina Ziekenhuis Stichting; 🇳🇱 Eindhoven, Netherlands

Amphia Hospital

🇳🇱Breda, Netherlands

Herbert van Wering

Site contact

0

hvanwering@amphia.nl