Clinical trial NCT06488170: A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting
Official title: Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plaque Psoriasis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of participants with diagnosis of moderate-to-severe plaque psoriasis in accordance with the SmPC.

Brief 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 criteria: 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 outcomes:
measure: Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
timeFrame: Baseline to Week 28
Secondary outcomes:
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline, Week 16 and 28
measure: Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline, Week 16 and 28
measure: Change from Baseline in Relative PASI Score
timeFrame: Baseline, Week 16 and 28
measure: Change from Baseline in Patient´s Assessment of Itch, Pain and Joint Pain as Measured by Numerical Rating Scale (NRS)
timeFrame: Baseline, Week 16 and 28
measure: Number of Participants Achieving Scalp Specific Physician's Global Assessment (PGA) Score
timeFrame: Baseline, Week 16 and 28
measure: Number of Participants Achieving Nail Specific PGA Score
timeFrame: Baseline, Week 16 and 28
measure: Number of Participants Achieving Palmoplantar PGA Score
timeFrame: Baseline, Week 16 and 28
measure: Number of Participants with Psoriasis (PSO) on Family and Partners by Family PSO Questionnaire
timeFrame: Baseline, Week 16 and 28
measure: Number of Participants with Psoriasis Treatment on Physician's Satisfaction
timeFrame: Baseline, Week 28
measure: Hospital Anxiety and Depression Scales (HADS) Questionnaire
timeFrame: Baseline, Week 16 and 28
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: Baseline, Week 16 and 28
measure: Correlations Between the Aforementioned Parameters, in Particular WHO-5 and HADS
timeFrame: Baseline, Week 16 and 28
measure: Correlations Between the Aforementioned Parameters, in Particular WHO-5 and FACIT-F
timeFrame: Baseline, Week 16 and 28
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Pilsen
country: Czechia
facility: Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady
city: Praha
country: Czechia
facility: University Hospital in Motol
Study officials:
affiliation: Almirall, S.A.
name: Study Director
role: STUDY_DIRECTOR
References: