A Cross-sectional and retrospective chart review study for assessing psoRiasis severitY by absolute PASI score in moderaTe to severe psoriatic pAtients routineLy treated with systemic treatment in Bulgaria, Estonia, Hungary, Latvia, Lithuania, Romania and Russia - The CRYSTAL Study

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Chart review study

Study drug and medical condition

• Medical condition to be studied:
  Psoriasis

Population studied

• Short description of the study population:
  Inclusion Criteria; • Male or female outpatients aged between 18 and 75 years old (inclusive) at the time of informed consent signature.; • Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist at the time of initiating the current systemic treatment for psoriasis.; • Patients currently treated with any approved systemic treatment for psoriasis, either as monotherapy or combination therapy, continuously for at least 24 weeks. • Patients with available absolute PASI score at the start of their current systemic treatment, and for whom the study physician plans to assess their absolute PASI score at the study visit as per his/her routine practice.; • Patients able to understand and communicate with the investigator and comply with the requirements of the study.; • Patients must be willing and able to read, understand and complete the provided patient questionnaires.; • Patients must provide written informed consent form (ICF) for collecting and analyzing their medical data pertinent to the objectives of this study.; ; Exclusion Criteria; • Patients not willing to participate in the study.; • Patients who are currently receiving treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  690

Study design details

• Main study objective:
  To characterize the current disease severity, by assessing the absolute Psoriasis Area Severity Index (PASI) score of patients with moderate to severe psoriasis that have been under continuous systemic treatment (either as monotherapy or as combination regimens) for at least 24 weeks.
• Outcomes:
  Mean absolute PASI score of the overall study population at enrollment. 1.To assess the absolute PASI <=1/<=3/<=5 response rates at enrollment, and to capture the duration of the current absolute PASI score, overall and by current systemic treatment option 2.To assess the absolute PASI >5 and >8 rates at enrollment, overall and by current systemic treatment option 3.To describe patient treatment history 4.To describe current systemic treatment for psoriasis
• Data analysis plan:
  Statistical analysis will be performed using SAS® statistical analysis software. Categorical variables will be presented as absolute and relative frequencies. For continuous variables, summary statistics will be tabulated. Correlations between continuous variables (i.e. HRQoL and absolute PASI score at enrollment) will be examined using Pearson’s or Spearman’s correlation coefficient, as applicable. The effect of factors of interest on the primary outcome variable (i.e. absolute PASI score at enrollment) will be assessed by general linear models i.e. linear regression model, Analysis of Variance (ANOVA), Analysis of Covariance (ANCOVA) using both the univariable and multivariable approach. All statistical analyses will be performed in the set of all eligible patients with available data.