NCT04823247Completed
Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study
A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study
Source: ClinicalTrials.gov · Last updated 11 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 782 (actual)
- First submitted
- 24 Mar 2021
- Start date
- 22 Nov 2021
- Primary completion date
- 9 Jan 2025
- Lead sponsor
- Almirall, S.A.
- Diseases
- Psoriasis
- NCT number
- NCT04823247
What you commit to
- Study type: Observational
- Participants enrolled: 782
- From 22 Nov 2021 to the primary completion date, 9 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haut- und Laserzentrum Freising Coordinator of this site? Confirm its status | Freising | Germany | Unknown status |
Related publications
- Patient-Reported Well-Being in Value-Based Routine Care in Psoriatic Disease Using Tildrakizumab: 2-Year Data of the Phase IV POSITIVE Study.Psoriasis (Auckl) · 2026 · PMID 42146323
This page is information, not medical advice. Discuss any trial with your doctor.