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

Study Overview
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Brief Summary
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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.

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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Tildrakizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tildrakizumab<br>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. | Drug: Tildrakizumab<br>* As provided in real world clinical practice.<br>* Other names: IL-23p19 inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score |  | Baseline and Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score |  | Baseline; 16 and 28 weeks; 12, 18 months after baseline visit | 
| Change from Baseline in Physician's Satisfaction Questionnaire Score |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Change from Baseline in FamilyPso Questionnaire Score |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Change From Baseline in Dermatology Life Quality Index-Relevant (DLQI-R) Score |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Change From Baseline in Treatment-related Patient Benefit Index 2.0 (PBI 2.0) Score |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) Score |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Skin Manifestations Distribution (Patient's Grid/Heat Map) |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Change from Baseline in Numerical Rating Scale (NRS) Scores for Itch, Pain, Joint Pain and Fatigue |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Change from Baseline in Psoriasis Area and Severity Index (PASI) Score |  | Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit | 
| Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics |  | From Baseline up to 24 months | 
| Number of Patients With Treatment-emergent Adverse Events (TEAE) |  | From Baseline up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate-to-severe plaque psoriasis, Psoriasis, Tildrakizumab, Prospective