Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals
- Sponsor
- LOGEX
- Study ID
- NCT07682038
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Colitis Ulcerative
- Crohn Disease
- Inflammatory Bowel Disease (IBD)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Routine hospital care data (observational) — OTHERThis 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.
Study Details
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.
Key Dates
- First listed
- Jul 2, 2026
- Start date
- Aug 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 3,500 participants (estimated)
Primary Outcome Measure
Treatment sequences and duration of conventional and advanced systemic therapies in CD and UC patients [ Time Frame: April 2018 - July 2026 ]
Find similar trials
Related Studies
- Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy ProjectRecruiting · University of California, San Diego · La Jolla, California
- Autologous Stem Cell Transplant for Crohn's DiseasePHASE2 · Recruiting · Aaron Etra · New York, New York
- Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVOPHASE1 · Recruiting · National Cancer Institute (NCI) · Sacramento, California
- Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF TherapyPHASE1/PHASE2 · Recruiting · Children's Hospital Medical Center, Cincinnati · Hartford, Connecticut