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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlmirall, S.A.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

primary or secondary treatment failure (PASI >= 3 or ΔPASI < 75 and/or DLQI > 5)

Disqualifiers

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.

Trial population

Adult male and female participants with moderate to severe plaque psoriasis will be observed in this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tildrakizumab

    Drug

    As provided in real-world clinical practice.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Tildrakizumab1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 28
2

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.

Time frame
Baseline up to Week 28

Secondary outcomes

1

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.

Time frame
Baseline, Week 4, 16 and 28
2

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.

Time frame
Baseline, Week 4, 16 and 28
3

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.

Time frame
Baseline, Week 4, 16 and 28
4

Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab

Time frame
At Baseline

Other outcomes

Sponsors and contacts

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