Clinical trial NCT04823247: Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study
Official title: A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Moderate-to-severe plaque psoriasis
Psoriasis
Tildrakizumab
Prospective
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2021-03-30
Enrollment: 782
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients with moderate-to-severe plaque psoriasis who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor treatment in real-world clinical practice.

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.


Eligibility 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.
* 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.

Primary outcomes:
measure: Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
timeFrame: Baseline and Month 24
Secondary outcomes:
measure: Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 months after baseline visit
measure: Change from Baseline in Physician's Satisfaction Questionnaire Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Change from Baseline in FamilyPso Questionnaire Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Change From Baseline in Dermatology Life Quality Index-Relevant (DLQI-R) Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Change From Baseline in Treatment-related Patient Benefit Index 2.0 (PBI 2.0) Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Skin Manifestations Distribution (Patient's Grid/Heat Map)
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Change from Baseline in Numerical Rating Scale (NRS) Scores for Itch, Pain, Joint Pain and Fatigue
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Change from Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
measure: Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics
timeFrame: From Baseline up to 24 months
measure: Number of Patients With Treatment-emergent Adverse Events (TEAE)
timeFrame: From Baseline up to 24 months
Other outcomes:
Locations:
city: Freising
country: Germany
facility: Haut- und Laserzentrum Freising
state: Bavaria
Study officials:
References: