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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030076
• Other study ID #: SW-ATCH
• Status: Recruiting
• Start date: September 6, 2023
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Almirall, S.A.
• Contact: Senior Director Regional Medical Affairs
• Phone: +43 0 15953960
• Email: medicalat[@]almirall.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent.

2. >=18 years of age.

3. Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFa antagonist, IL12/23 antagonist, IL17 antagonist).

4. Switch to tildrakizumab due to:

1. primary or secondary treatment failure (PASI >= 3 or ?PASI < 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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Tildrakizumab
As provided in real-world clinical practice.

Locations

Country	Name	City	State
Austria	Gesundheitszentrum Citypark Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score	TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.	Baseline, Week 28
Primary	World Health Organisation Well-Being Index (WHO-5) Score	The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.	Baseline up to Week 28
Secondary	Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score	The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.	Baseline, Week 4, 16 and 28
Secondary	Change from Baseline in Physician's Global Assessment (PGA) Score	The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.	Baseline, Week 4, 16 and 28
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) Score	The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.	Baseline, Week 4, 16 and 28
Secondary	Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab		At Baseline