Retrospective non-interventional chart review study of the relationship of fecal calprotectin and long-term outcomes in adult patients with Crohn's Disease to improve the quality of care in Finland (RECREFO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17191
• EU PAS number:
  EUPAS17190
• Study ID:
  17191
• Official title and acronym:
  Retrospective non-interventional chart review study of the relationship of fecal calprotectin and long-term outcomes in adult patients with Crohn's Disease to improve the quality of care in Finland (RECREFO)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  The study is an observational, retrospective, patient chart review study, whose population is adult patients with confirmed Crohn’s disease (CD) and who have initiated a biologic therapy at any time during the study period. The primary aim of the study is to investigate the association of fecal calprotectin (fCal) on the long-term clinical outcomes and health care resource use of CD patients. The secondary aim is to obtain a descriptive analysis of the current treatment pattern of CD patients in Finland.
• Study status:
  Ongoing

Research institution and networks

Institutions

Helsinki University Hospital (HYKS)

Peijas unit

Tampere University Hospital

Finland

Helsinki University Central Hospital Jorvi unit (HYKS) Helsinki, Finland, Turku University Central Hospital (TYKS) Turku, Finland, Tampere University Hospital (TAYS) Tampere, Finland

Study timelines

Date when funding contract was signed

Actual: 29/08/2016

Study start date

Actual: 31/10/2016

Data analysis start date

Planned: 01/02/2017

Date of interim report, if expected

Planned: 01/03/2017

Date of final study report

Planned: 01/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag

Regulatory

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