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 (FINUSTE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43156
• EU PAS number:
  EUPAS24728
• Study ID:
  43156
• 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 (FINUSTE)
• 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 year 2017. 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 and at the end of study period, and to determine the reasons for ustekinumab treatment discontinuation.
• Study status:
  Finalised

Research institution and networks

Institutions

Helsinki University Hospital (HYKS)

Helsinki University Central Hospital Meilahti unit (HYKS) Helsinki Finland, Helsinki University Central Hospital Jorvi unit (HYKS) Espoo Finland, Turku University Central Hospital TYKS Turku Finland, Tampere University Hospital TAYS Tampere Finland, Kuopio University Hospital KYS Kuopio Finland, South Carelia Central Hospital Lappeenranta Finland, Central Ostrobothnia Central Hospital Kokkola Finland, Vaasa Central Hospital Vaasa Finland, Satakunta Central Hospital Pori Finland, Kainuu Central Hospital Kajaani Finland, Päijät-Häme Central Hospital Lahti Finland, Central Finland Central Hospital Jyväskylä Finland, Lapland Central Hospital Rovaniemi Finland

Study timelines

Date when funding contract was signed

Actual: 03/04/2018

Study start date

Actual: 02/05/2018

Data analysis start date

Actual: 05/06/2018

Date of final study report

Planned: 30/09/2019

Actual: 11/06/2019

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?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable