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

NCT07682038 | Not Yet Recruiting

• 1 other identifier: W26.029
• Study Type: observational
• Target: 3,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn Disease; Inflammatory Bowel Disease (IBD); Colitis Ulcerative

Outcome Measures

Primary Outcomes (1)

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

  April 2018 - July 2026

Secondary Outcomes (2)

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

  April 2018 - July 2026

• Direct healthcare costs per patient per month

  April 2018 - July 2026

Other Outcomes (1)

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

  April 2018 - July 2026

Interventions

Routine hospital care data (observational) OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

secondary and tertiary care, outpatient clinics

You may qualify if:

• 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).
• Index date confirmation: the index date is defined as the first date of confirmed CD or UC diagnosis, requiring at least one healthcare encounter for CD or UC AND at least one prescription or dispensing record for any CD or UC-related medication within the observational period.

Sponsors & Collaborators

• LOGEX: lead

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share