Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLOGEX

About this trial

This multicenter retrospective real-world data study will evaluate the treatment pathways and disease burden of adult patients with Crohn's disease (CD) and ulcerative colitis (UC) treated in 5-10 Dutch hospitals between 2018 and 2026.

The study will assess:

* Treatment sequences, switching patterns, and treatment duration * Prevalence and incidence of extra-intestinal manifestations (EIMs) * Healthcare resource utilization (hospitalizations, outpatient visits, endoscopies, surgery, and length of stay) * Direct healthcare costs * Availability of disease activity biomarkers

Using linked administrative, prescription, procedure, and laboratory data, outcomes will be analyzed by age, line of therapy, and clinical characteristics. Special focus will be placed on the impact of EIMs on treatment patterns, healthcare utilization, and costs.

The findings will provide real-world evidence on IBD management in the Netherlands and support clinical decision-making, healthcare planning, and future research on treatment optimization and coexisting immune-mediated conditions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years of age) who required secondary (hospital) care after January 2018 with a confirmed diagnosis of CD or UC, defined by at least one ICD-10 diagnosis code for CD or UC (K50, K51, K52).

Disqualifiers

Patients who have formally objected to the use of their hospital data for scientific research purposes. Objections are recorded by the treating hospital in the DBC administrative system and automatically transferred to the research dataset, ensuring automatic exclusion from all analyses.

Trial population

secondary and tertiary care, outpatient clinics

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Routine hospital care data (observational)

    Other intervention

    This is a non-interventional, retrospective observational study. No intervention is administered as part of this study. The study observes and analyses routinely collected hospital data on existing treatment patterns for Crohn's disease and ulcerative colitis, including conventional therapies and advanced systemic treatments (biologics, JAK inhibitors, S1P modulators), as prescribed in routine clinical care.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Treatment sequences and duration of conventional and advanced systemic therapies in CD and UC patients

Time frame
April 2018 - July 2026

Secondary outcomes

1

Prevalence and incidence of extra-intestinal manifestations (EIMs) per patient per year

Time frame
April 2018 - July 2026
2

Direct healthcare costs per patient per month

Time frame
April 2018 - July 2026

Other outcomes

1

Availability and completeness of objective disease activity markers (fCal, CRP, ESR, serum albumin)

Time frame
April 2018 - July 2026

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: