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NCT Number: NCT04823247

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

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Key information

Conditions

Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haut- und Laserzentrum Freising

Freising, Bavaria, 85354, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tildrakizumab

Drug

As provided in real world clinical practice.

Other names: IL-23p19 inhibitor

Primary outcomes

  1. Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score

    Time frame: Baseline and Month 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

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

Acronym: POSITIVE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2021
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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