Retrospective non-interventional chart review study of the clinical outcomes of guselkumab in the treatment of Finnish patients with plaque psoriasis (FINGUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39377
• EU PAS number:
  EUPAS39376
• Study ID:
  39377
• Official title and acronym:
  Retrospective non-interventional chart review study of the clinical outcomes of guselkumab in the treatment of Finnish patients with plaque psoriasis (FINGUS)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  The study is an observational, retrospective, non-interventional patient chart review study, whose population is Finnish adult patients with confirmed diagnosis of plaque psoriasis (PSO) who have been initiated with guselkumab treatment between 1st December 2017 and 1st december 2019. The primary objective of the study is to investigate the real-life clinical outcomes, and drug survival of gusekumab treatment. The secondary objectives are to characterize the patients who initiated guselkumab treatment during the study timeline, to assess the dosing interval of guselkumab during the induction and maintenance phase of the treatment, to assess the reasons for discontinuation of guselkumab, and to estimate the patients' quality of life through DLQI, if available.
• Study status:
  Finalised

Research institutions and networks

Institutions

Tampere University Hospital

Finland

Tampere university hospital Tampere Finland, Vaasa central hospital Vaasa Finland, Kuopio university hospital Kuopio Finland, Lohja hospital (HUS) Lohja Finland,
Mikkeli central hospital Mikkeli Finland, Turku university central hospital Turku Finland, Ahvenanmaa central hospital Ahvenanmaa Finland, Helsinki university hospital Helsinki Finland, Central Finland central hospital Jyväskylä Finland, Oulu university hospital Oulu Finland, Savonlinna central hospital Savonlinna Finland,
Kanta-Häme central hospital Hämeenlinna Finland, Päijät-Häme central hospital Lahti Finland, Kainuu central hospital Kajaani Finland, Länsi-Pohja hospital Kemi Finland

Study timelines

Date when funding contract was signed

Actual: 14/11/2019

Study start date

Actual: 01/04/2020

Data analysis start date

Actual: 31/08/2020

Date of final study report

Actual: 18/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag Oy

Regulatory

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