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 (CD). 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 complex perianal fistula in Crohn's disease (CPF-CD). This study will assess tumorigenicity risk and all-cause and cancer-specific mortality in participants with darvadstrocel. The study will enroll approximately 5850 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.
Study Type
OBSERVATIONAL
1. Système National des Données de Santé (SNDS)
Charenton-le-Pont, France
Institut für angewandte Gesundheitsforschung Berlin (InGef)
Berlin, Germany
PHARMO
Utrecht, Netherlands
Estudio Nacional en Enfermedad Inflamatoria intestinal sobre Determinantes genéticos y Ambientales (ENEIDA)
Madrid, Spain
Incidence Rate of Malignancies Among Participants With CPF-CD
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.
Time frame: Up to Month 96
Cumulative Incidence of Malignancies Among Participants With CPF-CD
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.
Time frame: Up to Month 96
All-cause Mortality Rate Among Participants With CPF-CD
Time frame: Up to Month 96
Cancer-specific Mortality Rate Among Participants With CPF-CD
Time frame: Up to Month 96
Number of Participants With Anal Fistula Surgery
Time frame: Up to Month 96
Number of Participants With Colorectal Surgery
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.
Time frame: Up to Month 96
Number of Participants With CPF-CD Characterized by Pharmacological Therapies
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to Month 96
Number of Participants With Comorbidities
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.
Time frame: Up to Month 96