Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Tildrakizumab
As provided in real world clinical practice.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score [Baseline and Month 24]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
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Patient aged 18 years or older at the time of patient recruitment.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Haut- und Laserzentrum Freising | Freising | Bavaria | Germany | 85354 |
Sponsors and Collaborators
- Almirall, S.A.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M-14745-47