Clinical trial NCT04971525: A Study to Check How Often People Treated With Darvadstrocel for Crohn's Disease Are Diagnosed With Cancer
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Complex Perianal Fistula
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 5850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with CPF-CD who have been administered at least one dose of darvadstrocel and participants with CD and perianal fistula (PF) and no history of administration of darvadstrocel.

Brief 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 (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.

Detailed description: 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.

Eligibility criteria: 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 PF randomly selected from a pool of eligible participants with no history of administration of darvadstrocel.

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 different from non-melanoma skin cancer 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.

Primary outcomes:
measure: Incidence Rate of Malignancies Among Participants With CPF-CD
timeFrame: Up to Month 96
measure: Cumulative Incidence of Malignancies Among Participants With CPF-CD
timeFrame: Up to Month 96
Secondary outcomes:
measure: All-cause Mortality Rate Among Participants With CPF-CD
timeFrame: Up to Month 96
measure: Cancer-specific Mortality Rate Among Participants With CPF-CD
timeFrame: Up to Month 96
measure: Number of Participants With Anal Fistula Surgery
timeFrame: Up to Month 96
measure: Number of Participants With Colorectal Surgery
timeFrame: Up to Month 96
measure: Number of Participants With CPF-CD Characterized by Pharmacological Therapies
timeFrame: Up to Month 96
measure: Number of Participants With Comorbidities
timeFrame: Up to Month 96
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: 1. Système National des Données de Santé (SNDS)
city: Berlin
country: Germany
facility: Institut für angewandte Gesundheitsforschung Berlin (InGef)
city: Utrecht
country: Netherlands
facility: PHARMO
city: Madrid
country: Spain
facility: Estudio Nacional en Enfermedad Inflamatoria intestinal sobre Determinantes genéticos y Ambientales (ENEIDA)
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: