Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study

Almirall, S.A.782 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

782

Conditions

Plaque Psoriasis

Interventions

TildrakizumabDRUG

As provided in real world clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Haut- und Laserzentrum Freising

Freising, Bavaria, Germany

Outcomes

Primary Outcomes

Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score

Time frame: Baseline and Month 24