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

NCT04823247 | Completed FDA Drug

• 1 other identifier: M-14745-47
• Study Type: observational
• Target: 782
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Baseline and Month 24

Secondary Outcomes (12)

• 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

• Change from Baseline in Physician's Satisfaction Questionnaire Score

  Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit

• Change from Baseline in FamilyPso Questionnaire Score

  Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit

• 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

• 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

Study Arms (1)

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

Interventions

Tildrakizumab DRUG

As provided in real world clinical practice.

Also known as: IL-23p19 inhibitor

Tildrakizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Haut- und Laserzentrum Freising

Freising, Bavaria, 85354, Germany

Location

Related Publications (2)

• 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.

  PMID: 40605963 DERIVED

• 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.

  PMID: 36792337 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

tildrakizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 30, 2021
• Study Start: November 22, 2021
• Primary Completion: January 9, 2025
• Study Completion: January 9, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)