An Observational Post-authorization Safety Study to Describe the Safety of Ustekinumab and Other Crohn’s Disease Treatments in a Cohort of Patients With Crohn’s Disease

Study identification

• EU PAS number:
  EUPAS21954
• Study ID:
  48842
• Official title and acronym:
  An Observational Post-authorization Safety Study to Describe the Safety of Ustekinumab and Other Crohn’s Disease Treatments in a Cohort of Patients With Crohn’s Disease
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  France

  Germany

  Greece

  Hungary

  Ireland

  Israel

  Italy

  Netherlands

  Poland

  Portugal

  Spain

  Sweden

  United Kingdom
• Study description:
  This is an observational, post-authorization safety study to describe the safety profile of adult patients with CD enrolled into the I-CARE study – an independent, ongoing, prospective, observational, multicenter cohort study. This study will include patients who receive ustekinumab treatment and those receiving other CD treatments within routine clinical practice, using data collected in the I-CARE study. The source population is derived from the I-CARE study, enrolling patients with CD, ulcerative colitis or IBD at sites in 16 countries across Europe. This study will focus primarily on patients enrolled into I-CARE who are being treated for CD with ustekinumab. Patients enrolled into I CARE will complete an electronic-diary on a monthly basis and an e-PRO questionnaire on a yearly basis. Additionally, a gastroenterologist will complete an annual summary at least once yearly. Patients enrolled in the study will be observed for 3 years. The final patient population of the I-CARE study will be at least 10,000 IBD patients split into 6 patient groups, with approximately 2,000 patients in the ustekinumab cohort of CD patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Groupe d'Étude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID)

Networks

Groupe d’Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)

Study timelines

Date when funding contract was signed

Planned: 10/12/2017

Actual: 20/11/2017

Study start date

Planned: 31/12/2019

Actual: 15/12/2017

Date of final study report

Planned: 30/09/2023

Actual: 26/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Pharmaceutica NV

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)