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

Almirall

Status: Completed

Conditions: Plaque Psoriasis

Treatments: Drug: Tildrakizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04823247

M-14745-47

Details and patient eligibility

About

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.

Enrollment: 782 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

782 participants in 1 patient group

Tildrakizumab

Description:

Patients diagnosed with moderate-to-severe plaque psoriasis who require systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor in real-world clinical practice, following the routine clinical practice on each patient country, will be observed for 24 months.

Treatment:

Drug: Tildrakizumab