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

Plaque Psoriasis Clinical Trial

— POSITIVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04823247
• Other study ID #: M-14745-47
• Status: Active, not recruiting
• Start date: November 22, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 782
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Tildrakizumab
As provided in real world clinical practice.

Locations

Country	Name	City	State
Germany	Haut- und Laserzentrum Freising	Freising	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score		Baseline and Month 24
Secondary	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
Secondary	Change from Baseline in Physician's Satisfaction Questionnaire Score		Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Secondary	Change from Baseline in FamilyPso Questionnaire Score		Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Skin Manifestations Distribution (Patient's Grid/Heat Map)		Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Secondary	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
Secondary	Change from Baseline in Psoriasis Area and Severity Index (PASI) Score		Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Secondary	Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics		From Baseline up to 24 months
Secondary	Number of Patients With Treatment-emergent Adverse Events (TEAE)		From Baseline up to 24 months