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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04971525
• Other study ID #: Alofisel-5005
• Status: Active, not recruiting
• Start date: April 3, 2023
• Est. completion date: November 13, 2026

Study information

• Verified date: April 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5850
• Est. completion date: November 13, 2026
• Est. primary completion date: November 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Darvadstrocel cohort

1. Participants will be included in the darvadstrocel cohort if they have at least one record of prescription/dispensation/administration of darvadstrocel at some point during the study period.

Comparator cohort

1. A comparator cohort of controls (matched control cohort) will be composed of participants with CD and PAF randomly selected from a pool of eligible participants with no history of administration of darvadstrocel.

2. Has any other management of CPAF different to darvadstrocel, from no treatment to any other treatment.

Exclusion Criteria:

1. Has less than 12 months of uninterrupted data within country-specific data source prior to index date.

2. Has not meet quality indicators for country-specific data source (if applicable).

3. Has diagnosis of cancer prior to index date. This will minimise the misclassification of prevalent or metastatic cancer as incident cases for the analysis of the study objectives.

4. Has diagnosis of ulcerative colitis at any point during the study period and medical history period. This will avoid potential ascertainment bias as there is currently no gold standard for differential diagnosis in IBD. Approximately 5 percent (%) to 15% of cases do not meet strict criteria for either ulcerative colitis (UC) or CD and in up to 14% of participants classified as UC and CD, the diagnosis changes over time.

5. Has record of proctectomy or colectomy prior to index date. Proctectomy and colectomy are considered "last chance" surgery options for anal fistulas or other complications of CD. These participants are not the target population for darvadstrocel. They would not be eligible for darvadstrocel administration and loss of their gastrointestinal tract would affect the risk of colorectal cancer; the most common cancer associated with CD.

Related Conditions & MeSH terms

• Complex Perianal Fistula
• Crohn Disease
• Fistula

Locations

Country	Name	City	State
France	1. Système National des Données de Santé (SNDS)	Charenton-le-Pont
Germany	Institut für angewandte Gesundheitsforschung Berlin (InGef)	Berlin
Netherlands	PHARMO	Utrecht
Spain	Estudio Nacional en Enfermedad Inflamatoria intestinal sobre Determinantes genéticos y Ambientales (ENEIDA)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Malignancies in Crohn's Disease (CD) Participants With Perianal Fistula (PAF)	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.	Up to Month 96
Primary	Cumulative Occurrence of Malignancies in CD Participants With PAF	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.	Up to Month 96
Secondary	All-cause Mortality Rate in CD Participants With PAF		Up to Month 96
Secondary	Cancer-specific Mortality rate in CD Participants With PAF		Up to Month 96
Secondary	Number of Participants With Anal Fistula Surgery		Up to Month 96
Secondary	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.	Up to Month 96
Secondary	Number of CD Participants With PAF 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.	Up to Month 96
Secondary	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.	Up to Month 96

External Links

•   To obtain more information on the study, click here/on this link.