Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Tildrakizumab
Moderate-to-severe plaque psoriasis
Prospective
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female participants with moderate to severe plaque psoriasis will be observed in this study.

Brief summary: 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.

Primary outcomes:
measure: Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score
timeFrame: Baseline, Week 28
measure: World Health Organisation Well-Being Index (WHO-5) Score
timeFrame: Baseline up to Week 28
Secondary outcomes:
measure: Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline, Week 4, 16 and 28
measure: Change from Baseline in Physician's Global Assessment (PGA) Score
timeFrame: Baseline, Week 4, 16 and 28
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline, Week 4, 16 and 28
measure: Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab
timeFrame: At Baseline
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Gesundheitszentrum Citypark Graz
state: Styria
Study officials:
References: