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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
NCT06030076 · Almirall, S.A.
In plain English
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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
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Written informed consent.
2. \>=18 years of age.
3. Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
4. Switch to tildrakizumab due to:
1. primary or secondary treatment failure (PASI \>= 3 or ΔPASI \< 75 and/or DLQI \> 5)
2. adverse events, contraindication, intolerance
3. patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason
5. Treatment with tildrakizumab planned in the frame of clinical practice.
Exclusion Criteria:
1. 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.
2. \>=3 previous biologic treatments in the last 3 years.
3. Participation in a clinical trial simultaneous to participation in SW-ATCH.
4. Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
5. Patient dependent on the Investigator.
6. Previous treatment with Tildrakizumab.
Study design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-09-06
Estimated completion: 2025-10
Last updated: 2025-01-29
Interventions
Drug: Tildrakizumab
Primary outcomes
- • Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score (Baseline, Week 28)
- • World Health Organisation Well-Being Index (WHO-5) Score (Baseline up to Week 28)
Sponsor
Almirall, S.A. · industry
Contacts & investigators
ContactSenior Director Regional Medical Affairs · contact · medicalat@almirall.com · +43 0 15953960
All locations (1)
Gesundheitszentrum Citypark GrazRecruiting
Graz, Styria, Austria