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临床试验/NCT07682038
NCT07682038尚未招募不适用

Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals

LOGEX0 个研究点目标入组 3,500 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,500
主要终点
Treatment sequences and duration of conventional and advanced systemic therapies in CD and UC patients

研究概览

简要总结

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.

详细描述

Inflammatory bowel disease (IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC), is a chronic, relapsing inflammatory disorder of the gastrointestinal tract with an increasing global burden. Patients frequently require lifelong management and may experience substantial healthcare resource utilization (HCRU) throughout the course of their disease. Beyond intestinal symptoms, many patients develop extra-intestinal manifestations (EIMs), including rheumatological, dermatological, ophthalmological, and pulmonary conditions, which further increase disease complexity and healthcare burden.

Over the past decade, therapeutic options for IBD have expanded considerably. In addition to conventional treatments such as corticosteroids, thiopurines, methotrexate, and aminosalicylates, multiple classes of advanced systemic therapies (ASTs) are now available, including anti-TNF agents, anti-integrin therapies, anti-IL-12/23 therapies, JAK inhibitors, and S1P receptor modulators. Despite these advances, long-term remission remains challenging for many patients, and there is limited real-world evidence describing how therapies are used in routine Dutch clinical practice, including treatment sequencing, treatment duration, healthcare resource utilization, and outcomes associated with EIMs.

This study aims to address these evidence gaps by generating real-world insights into treatment patterns, EIM burden, healthcare utilization, and costs among patients with CD and UC treated in Dutch hospitals. The findings are intended to support clinical decision-making, healthcare planning, and future research on IBD management in the Netherlands.

Study Design Retrospective, observational, multicenter real-world data cohort study using routinely collected healthcare data from 5 to 10 participating Dutch hospitals. The observational period runs from 1 January 2018 through 31 July 2026 and is fully closed prior to any data extraction. Data are extracted and pseudonymized within participating hospitals before transfer for analysis. No patient contact occurs and no additional data are collected.

Data sources include administrative and claims data, diagnosis registrations, prescription data, electronic prescribing system (EVS) data, laboratory databases, surgical and endoscopy activity data, and intramural medication records. Laboratory data may include fecal calprotectin (fCal), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum albumin, and therapeutic drug monitoring results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: April 2018 - July 2026

次要结局

  • Direct healthcare costs per patient per month(April 2018 - July 2026)
  • Prevalence and incidence of extra-intestinal manifestations (EIMs) per patient per year(April 2018 - July 2026)

研究者

发起方
LOGEX
申办方类型
Industry
责任方
Sponsor

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