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

NCT ID: NCT04823247

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 782 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-22
• Study Completion Date: 2025-01-09

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.

Conditions

Plaque Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Tildrakizumab

Intervention Type: DRUG

As provided in real world clinical practice.

Interventions

Tildrakizumab

As provided in real world clinical practice.

Intervention Type: DRUG

Other Intervention Names

IL-23p19 inhibitor

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Haut- und Laserzentrum Freising

Freising, Bavaria, Germany

Countries

Germany

References

Mrowietz U, Sommer R, Gerdes S, Reguiai Z, Weger W, Dauden E, Maul JT, Ghislain PD, Laws PM, Naldi L, De Jong E, Mburu S, Koscielny V, Massana E, Domenech A, Gaarn du Jardin K, Kasujee I, Augustin M. Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study. Psoriasis (Auckl). 2025 Jun 28;15:243-259. doi: 10.2147/PTT.S526748. eCollection 2025.

Reference Type: DERIVED

PMID: 40605963 (View on PubMed)

Augustin M, Sommer R, Dauden E, Laws P, de Jong E, Fabbrocini G, Naldi L, Navarini A, Lambert J, Reguiai Z, Gerdes S, Massana E, Obis T, Kasujee I, Mrowietz U. Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study). BMJ Open. 2023 Feb 15;13(2):e060536. doi: 10.1136/bmjopen-2021-060536.

Reference Type: DERIVED

PMID: 36792337 (View on PubMed)

Other Identifiers

M-14745-47

Identifier Type: -

Identifier Source: org_study_id