Retrospective non-interventional chart review study of the dosing and short-term clinical outcomes of patients with Crohn’s Disease treated with ustekinumab in Finland (FINUSTE2)

Study identification

• EU PAS number:
  EUPAS30920
• Study ID:
  43159
• Official title and acronym:
  Retrospective non-interventional chart review study of the dosing and short-term clinical outcomes of patients with Crohn’s Disease treated with ustekinumab in Finland (FINUSTE2)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  The study is an observational, retrospective, non-interventional patient chart review study, whose population is adult patients with confirmed Crohn’s disease (CD) and who have initiated an intravenous ustekinumab therapy during years 2017 and 2018. The primary objective of the study is to investigate the real-life dosing patterns and the positioning of ustekinumab in the treatment of CD patients in Finland. The secondary objectives are to determine the proportion of patients continuing treatment with ustekinumab at the time of data collection, to evaluate the change in effectiveness from baseline (measured by Harvey-Bradshaw index, endoscopic score SES-CD) at 16 weeks, 1 year, 1.5 years, 2 years, and at the end of study period, and to determine the reasons for ustekinumab treatment discontinuation. This study is an extension amendment of the original FINUSTE study (EUPAS24728). In the amendment, data collection time was extended by one year (until 30.4.2019), and four new study sites were included in the study. Data collection points of 1 year, 1,5 years and 2 years were added as well, along with some minor changes. Although FINUSTE2 is not an independent study, it is registered as a separate study for clarity and transparency.
• Study status:
  Finalised

Research institutions and networks

Institutions

Helsinki University Hospital (HYKS)

A list of participating centres is provided in a separate document in section 19. Please see the attachment

Study timelines

Date when funding contract was signed

Actual: 20/03/2019

Study start date

Actual: 02/05/2019

Data analysis start date

Planned: 26/08/2019

Actual: 12/08/2019

Date of final study report

Planned: 30/09/2020

Actual: 05/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag AB

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

EUPAS24728 (FINUSTE)