Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study
- Registration Number
- NCT04823247
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tildrakizumab Tildrakizumab 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score Baseline and Month 24
- Secondary Outcome Measures
Name Time Method 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 Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics From Baseline up to 24 months 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 With Treatment-emergent Adverse Events (TEAE) From Baseline up to 24 months
Trial Locations
- Locations (1)
Haut- und Laserzentrum Freising
🇩🇪Freising, Bavaria, Germany