Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study (POSITIVE)

A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Tildrakizumab

• Study Type: Observational
• Enrollment (Actual): 782

Contacts and Locations

• Study Contact: Name: Èric Massana; Phone Number: 0034 932 913 986; Email: eric.massana@almirall.com

Study Locations

• Germany
  • Bavaria
    • Freising, Bavaria, Germany, 85354
      • Haut- und Laserzentrum Freising

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: IL-23p19 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score	Baseline and Month 24

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Psoriasis; Prospective; Tildrakizumab; Moderate-to-severe plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Interleukin-23
• Other Study ID Numbers: M-14745-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No