An Observational European Multi-database Linkage Study to Quantify Malignancy Rates in Crohn’s Disease Patients With Complex Perianal Fistula Treated With Darvadstrocel (Alofisel-5005)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103350
• EU PAS number:
  EUPAS41643
• Study ID:
  103350
• Official title and acronym:
  An Observational European Multi-database Linkage Study to Quantify Malignancy Rates in Crohn’s Disease Patients With Complex Perianal Fistula Treated With Darvadstrocel (Alofisel-5005)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands

  Spain
• Study description:
  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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 20/06/2019

Study start date

Planned: 14/03/2023

Actual: 04/03/2023

Date of final study report

Planned: 29/10/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)