NCT02517684CompletedPhase 4
Top-down Infliximab Study in Kids With Crohn's Disease
Source: ClinicalTrials.gov · Last updated 5 Mar 2024
Brief summary (registry, in English)
The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 1 Jul 2015
- Start date
- 1 Apr 2015
- Primary completion date
- 31 Dec 2019
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Crohn's disease
- NCT number
- NCT02517684
- EudraCT number
- 2014-005702-37
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 100
- From 1 Apr 2015 to the primary completion date, 31 Dec 2019
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- immediate need for surgery,
- those already started with CD specific therapy,
Other illness
- severe infection such as sepsis or opportunistic infections,
- positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy,
Other
- Patients with the following characteristics will be excluded:
- symptomatic stenosis or stricture in the bowel due to scarring,
- active perianal fistulas,
- severe co-morbidity,
- positive stool culture,
- positive Clostridium difficile assay,
- patients with a suspected or
- definitive pregnancy
Who the study is looking for
- Children (age 3-17 years, both male and female, weight \>10kg) with new-onset,
- untreated CD with moderate-to-severe disease activity assessed by a wPCDAI \>40 will be eligible for inclusion after a diagnosis of CD was made based on the Porto criteria
Age in the registry: 3 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Brussels Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| University Hospitals Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Helsinki University Central Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| VU University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Academic Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Maasstad Hospital Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Isala Hospital Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.