Skip to content

Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients (Pro-RAPID)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507352-72-00
Acronym
NL81536.078.22
Enrollment
50
Registered
2024-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief summary

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

Detailed description

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

Interventions

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026