Digestive System Diseases

All Conditions

Symptoms and General Pathology

Crohn Disease

Fistula

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Pathological Conditions, Anatomical

Participants diagnosed with CD and CPAF, who administered at least one dose of darvadstrocel in fistula tract tissue under surgical environment will be observed.

Participants diagnosed with CD and PAF with no history of administration of darvadstrocel, matched age at index date (within 3 years), time from CD diagnosis (within 1 year), and sex to individuals in the darvadstrocel cohort who received the alternative Standard of Care (SoC), which varies from country to country and according to local centre expertise will be observed.

Study Director

The main aim is to learn about the risk of cancer after treatment with darvadstrocel compared to other standards of care in people with Crohn's Disease.

In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

This is a retrospective, non-interventional study of participants with CD and CPAF. This study will assess tumorigenicity risk and all-cause and cancer-specific mortality in participants with darvadstrocel.

The study will enroll approximately 13,080 participants. Data will be collected retrospectively from European secondary data sources. Participants will be assigned to two cohorts:

* Darvadstrocel cohort
* Matched control cohort: Alternate SoC.

This multi-center trial will be conducted in France, Germany, Netherlands, and Spain. The overall duration of the study will be approximately 96 months, including index period (the time in which eligible participants are included in the study) and 12 months follow-up period.

A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer

An Observational European Multi-database Linkage Study to Quantify Malignancy Rates in Crohn's Disease Patients With Complex Perianal Fistula Treated With Darvadstrocel

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Incidence rate of malignancies will be calculated as the number of newly observed cases divided by the person-years of follow-up during that period.

Cumulative incidence rate within a period will be calculated as the ratio of newly observed cases divided by the population at risk during that period.

Colorectal surgery such as colectomy and proctectomy modify colorectal cancer risk. Colorectal surgery will be identified using procedure codes specific to each country-specific data source.

Thiopurines and methotrexate have been found to increase the risk of lymphoma and skin cancer. These drugs will be identified in outpatient prescription data using Anatomical Therapeutic Chemical (ATC) codes. In the case of in-hospital administered drugs, such as anti-tumour necrosis factor's (anti-TNF) and biologics, drugs will be defined using relevant ATC codes and/or procedure codes available in the hospital records.

Comorbidities will be identified using International Classification of Diseases 10th revision (ICD-10 codes) (or country specific modifications) within hospital settings in each country-specific data source.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer	NCT04971525	Crohn Disease Complex Periana...		18 Years -	Takeda
A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer	NCT04971525	Crohn Disease Complex Periana...		18 Years -	Takeda

Spots Global Cancer Trial Database for complex perianal fistula