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
Recruiting · NCT06030076 · Observational (researchers observe without assigning treatment) · Lead sponsor: Almirall, S.A.
View the official record on ClinicalTrials.gov →Interventions studied
Tildrakizumab
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Gesundheitszentrum Citypark Graz - Graz, Styria, Austria