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NCT Number: NCT06030076

A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis

The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gesundheitszentrum Citypark Graz

Graz, Styria, 8010, Austria

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent.
  • >=18 years of age.
  • Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
  • Switch to tildrakizumab due to:
  • primary or secondary treatment failure (PASI >= 3 or ΔPASI < 75 and/or DLQI > 5)
  • adverse events, contraindication, intolerance
  • patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason
  • Treatment with tildrakizumab planned in the frame of clinical practice.

Exclusion criteria

  • Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
  • >=3 previous biologic treatments in the last 3 years.
  • Participation in a clinical trial simultaneous to participation in SW-ATCH.
  • Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
  • Patient dependent on the Investigator.
  • Previous treatment with Tildrakizumab.

Treatment and study plan

Tildrakizumab

Drug

As provided in real-world clinical practice.

Other names: Ilumetri®

Primary outcomes

  1. Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score

    Time frame: Baseline, Week 28

    TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.

  2. World Health Organisation Well-Being Index (WHO-5) Score

    Time frame: Baseline up to Week 28

    The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

Secondary outcomes

  1. Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score

    Time frame: Baseline, Week 4, 16 and 28

    The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.

  2. Change from Baseline in Physician's Global Assessment (PGA) Score

    Time frame: Baseline, Week 4, 16 and 28

    The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.

  3. Change from Baseline in Dermatology Life Quality Index (DLQI) Score

    Time frame: Baseline, Week 4, 16 and 28

    The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.

  4. Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab

    Time frame: At Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Senior Director Regional Medical Affairs

CONTACT

[email protected]

+43 0 15953960

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

A Non-interventional, Prospective Cohort, Multicentre, Real-world Evidence Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis in Austria and Switzerland

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Jan 29, 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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