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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, retrospective patient chart review study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ADALIMUMAB

  INFLIXIMAB

  VEDOLIZUMAB
• Medical condition to be studied:
  Crohn's disease

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  To investigate the association of fCal and the long-term course of clinical evolution and health-care resource utilization in adult CD patients.
• Outcomes:
  The primary goal of the analysis is to associate fCal 12 months after initiation of therapy with surgery free survival over time. Primary complementary objectives are to assess the simple correlations and potentially the more comprehensive impact of fCal and surgery free survival. The secondary goal of the analysis is to associate fCal 12 months after initiation of biologic therapy with other health care resource utilization and outcomes that will affect resource utilization and to gain a description of the current CD treatment pattern in Finland.
• Data analysis plan:
  Statistical tests on univariate comparisons are done. Estimation of the survival or treatment failure is based on suitable methods, such as univariate and multivariate hazard or multivariate survival models. Where feasible, point estimates with interval estimates (confidence intervals or standard errors) are presented. P-value lower than 0.050 is considered statistically significant.