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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tildrakizumab.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Tildrakizumab
As provided in real-world clinical practice.
Primary outcome measures
- Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score [Time frame: Baseline, Week 28]
- World Health Organisation Well-Being Index (WHO-5) Score [Time frame: Baseline up to Week 28]
Secondary outcome measures (4)
- Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score [Time frame: Baseline, Week 4, 16 and 28]
- Change from Baseline in Physician's Global Assessment (PGA) Score [Time frame: Baseline, Week 4, 16 and 28]
- Change from Baseline in Dermatology Life Quality Index (DLQI) Score [Time frame: Baseline, Week 4, 16 and 28]
- Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab [Time frame: At Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Gesundheitszentrum Citypark Graz — Graz
Identifiers
NCT: NCT06030076 · SW-ATCH