A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study

M-14745-47

This is an ethics-approved, multi-national, multi-site Phase IV, 1-cohort prospective observational study. The main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item World Health Organization Wellbeing Index (WHO-5) questionnaire.

2021-11-22

2024-12-01

2024-12-01

Active (not recruiting)

782

Inclusion Criteria: * Patient with diagnosis of moderate-to-severe chronic plaque psoriasis documented in the medical chart. * Patient who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-IL-23p19 selected therapy before including the patient in the study. * Patient aged 18 years or older at the time of patient recruitment. * Patient who have provided written informed consent (if required by country regulations). Exclusion Criteria: * Patients unable to comply with the requirements of the study (fulfilling of the study questionnaires) or who, in the opinion of the study physician, should not participate in the study. * Patients included in a clinical trial.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '24 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 782, 'type': 'ACTUAL'}}

2023-07-21