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

NCT04971525 | Withdrawn

• 1 other identifier: Alofisel-5005
• Study Type: observational
• Target: N/A
• Locations: 4 countries
• Sites: 4

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.

Conditions

Crohn Disease; Complex Perianal Fistula

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to Month 96

Secondary Outcomes (6)

• All-cause Mortality Rate Among Participants With CPF-CD

  Up to Month 96

• Cancer-specific Mortality Rate Among Participants With CPF-CD

  Up to Month 96

• Number of Participants With Anal Fistula Surgery

  Up to Month 96

• Number of Participants With Colorectal Surgery

  Up to Month 96

• Number of Participants With CPF-CD Characterized by Pharmacological Therapies

  Up to Month 96

Study Arms (2)

Darvadstrocel Cohort

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

Matched Control Cohort: Standard of Care (SoC)

Participants diagnosed with CPF-CD with no history of administration of darvadstrocel, matched age at index date (within 3 years), sex and if feasible, complex perianal fistula (CPF) diagnosis (within 1 year) 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• \. 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.

You may not qualify if:

• Has less than 12 months of uninterrupted data within country-specific data source prior to index date.
• Has not meet quality indicators for country-specific data source (if applicable).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

1. Système National des Données de Santé (SNDS)

Charenton-le-Pont, 94220, France

Location

Institut für angewandte Gesundheitsforschung Berlin (InGef)

Berlin, Berlin, Germany, Germany

Location

PHARMO

Utrecht, 3528, Netherlands

Location

Estudio Nacional en Enfermedad Inflamatoria intestinal sobre Determinantes genéticos y Ambientales (ENEIDA)

Madrid, Spain

Location

Related Links

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

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 21, 2021
• Study Start: April 3, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

FR (1); DE (1); NL (1); ES (1)