Actively Recruiting
A Non-interventional, Prospective Cohort Study to Assess Effects of Switching to Tildrakizumab in Adults with Moderate to Severe Plaque Psoriasis
Led by Almirall, S.A. · Updated on 2025-01-29
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of switching from another biologic treatment to tildrakizumab in adults with moderate to severe plaque psoriasis. It focuses on patient-reported outcomes, psoriasis severity, quality of life before and after switching, and the reasons patients choose to change biologic therapies. The study is observational and takes place in real-world clinical settings. Participants prescribed tildrakizumab according to routine clinical practice will be observed for up to 28 weeks. The study does not involve assigning treatments but follows patients who switch to tildrakizumab as part of their care. Researchers will track changes in psoriasis severity and patient satisfaction with medication over this period. During the study, participants will complete questionnaires such as the Treatment Satisfaction Questionnaire for Medication-11 and the World Health Organisation Well-Being Index at the start and after 28 weeks. Psoriasis severity and quality of life will also be assessed at multiple time points using clinical scores and patient questionnaires. The study monitors participants' health and treatment satisfaction throughout the observation period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent.
- 18 years of age or older.
- Diagnosed with moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFB1 antagonist, IL12/23 antagonist, IL17 antagonist).
- Planned switch to tildrakizumab due to treatment failure, adverse events, intolerance, patient preference, or other reasons.
- Treatment with tildrakizumab planned as part of clinical practice.
You will not qualify if you...
- Unable or unwilling to comply with study requirements.
- Received three or more biologic treatments in the last three years.
- Participating in another clinical trial at the same time.
- Any condition preventing prescription of tildrakizumab according to product guidelines, including hypersensitivity or intolerance.
- Dependent on the Investigator.
- Previous treatment with tildrakizumab.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 weeks
Participants who have been prescribed tildrakizumab as part of routine clinical practice are observed prospectively to assess treatment effects using patient-reported outcomes and clinical assessments.
Visits at Baseline, Week 4, Week 16, and Week 28
Trial Site Locations
Total: 1 location
1
Gesundheitszentrum Citypark Graz
Graz, Styria, Austria, 8010
Actively Recruiting
Research Team
S
Senior Director Regional Medical Affairs
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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