Plaque Psoriasis
Conditions
Keywords
Moderate-to-severe plaque psoriasis, Psoriasis, Tildrakizumab, Prospective
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.
Interventions
DRUGTildrakizumab
As provided in real world clinical practice.
Sponsors
Almirall, S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score | Baseline and Month 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 5-item World Health Organization Wellbeing Index (WHO-5) Score | Baseline; 16 and 28 weeks; 12, 18 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 |
| 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 |
Countries
Germany
Outcome results
None listed