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

• ClinicalTrials.gov Identifier: NCT04823247
• Recruitment Status: Active, not recruiting
• First Posted: March 30, 2021
• Last Update Posted: July 21, 2023
• Sponsor: Almirall, S.A.
• Information provided by (Responsible Party): Almirall, S.A.

Study Description

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.

Condition or disease	Intervention/treatment
Plaque Psoriasis	Drug: Tildrakizumab

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 782 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Official Title: A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study
• Actual Study Start Date: November 22, 2021
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 2024

Groups and Cohorts

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 Name: IL-23p19 inhibitor

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score [ Time Frame: Baseline and Month 24 ]

Secondary Outcome Measures :

1. Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 months after baseline visit ]
2. Change from Baseline in Physician's Satisfaction Questionnaire Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
3. Change from Baseline in FamilyPso Questionnaire Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
4. Change From Baseline in Dermatology Life Quality Index-Relevant (DLQI-R) Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
5. Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
6. Change From Baseline in Treatment-related Patient Benefit Index 2.0 (PBI 2.0) Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
7. Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
8. Skin Manifestations Distribution (Patient's Grid/Heat Map) [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
9. Change from Baseline in Numerical Rating Scale (NRS) Scores for Itch, Pain, Joint Pain and Fatigue [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
10. Change from Baseline in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit ]
11. Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics [ Time Frame: From Baseline up to 24 months ]
12. Number of Patients With Treatment-emergent Adverse Events (TEAE) [ Time Frame: From Baseline up to 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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.

Contacts and Locations

Locations

Germany

Haut- und Laserzentrum Freising

Freising, Bavaria, Germany, 85354

Sponsors and Collaborators

Almirall, S.A.

More Information

• Responsible Party: Almirall, S.A.
• ClinicalTrials.gov Identifier: NCT04823247
• Other Study ID Numbers: M-14745-47
• First Posted: March 30, 2021
• Last Update Posted: July 21, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Almirall, S.A.:

Moderate-to-severe plaque psoriasis; Psoriasis; Tildrakizumab; Prospective

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Interleukin-23; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents