Clinical Trials in Czechia / NCT06488170
Active, not recruiting
Observational
A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting
NCT06488170 · tracked via the Priya Life Science Czechia tracker
Condition(s) studied
Plaque Psoriasis
Investigational drug(s) / intervention(s)
Tildrakizumab: As provided in real world clinical practice.
Study summary
The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).
Eligibility
Inclusion Criteria:
* Participant with diagnosis of moderate or severe chronic plaque PSO documented in the medical chart.
* Participant who needs systemic biologic therapy and qualifies for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-Il-23p19 selected therapy before including the patient in the study.
* Participant aged greater than or equal to (\>=) 18 years at Inclusion.
* Written informed consent.
Exclusion Criteria:
* Participant unable or unwilling to comply with the requirements of the study.
* Participant who should not participate in the study for any reason at the discretion of the treating physician.
* Participants participating in a simultaneous clinical trial.
* Any contraindication against the use of Tildrakizumab according to the SmPC.
* Exposure to \>= 3 biologics prior to inclusion.
* Participant dependent on the investigator, e.g. as employee
Primary outcome measure(s)
- Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score — Baseline to Week 28
The WHO-5 is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life. The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Ostrava | Ostrava | Czechia | |
| Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše | Pilsen | Czechia | |
| University Hospital Kralovske Vinohrady | Prague | Czechia | |
| University Hospital in Motol | Prague | Czechia | |
| General university hospital Prague | Prague | Czechia | |
| University Hospital Bulovka | Prague | Czechia | |
| Masarykova hospital Ústí nad Labem | Ústí nad Labem | Czechia |
Other trials for the same condition
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Active, not recruiting
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06488170 on ClinicalTrials.gov ↗ ← All trials in Czechia