A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting
NCT Number: NCT06488170
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Plaque Psoriasis
Interventions: DRUG: Tildrakizumab
Sponsor: Almirall, S.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-04
Completion Date: 2025-01
Locations: University Hospital Ostrava, Ostrava, 708 52, Czechia|Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše, Pilsen, 301 00, Czechia|University Hospital Kralovske Vinohrady, Prague, 100 00, Czechia|University Hospital in Motol, Praha, 150 06, Czechia

Summary:
The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).

Primary Outcome Measures: Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score, The WHO-5 is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life. The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being., Baseline to Week 28
Secondary Outcome Measures: Change From Baseline in Dermatology Life Quality Index (DLQI) Score, DLQI is a dermatology-specific instrument used to measure the impact of skin diseases on patients' quality of life. Which assessed disease impact, monitor treatment effectiveness, guide clinical decision-making. Interpretation of Scores: 0-1: No effect on patient's life 2-5: Small effect on patient's life 6-10: Moderate effect on patient's life 11-20: Very large effect on patient's life 21-30: Extremely large effect on patient's life., Baseline, Week 16 and 28|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 16 and 28|Change from Baseline in Relative 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 16 and 28|Change from Baseline in Patient´s Assessment of Itch, Pain and Joint Pain as Measured by Numerical Rating Scale (NRS), NRS is the simplest and most commonly used scales to indicate the degree of pain, itch, and discomfort. The numerical scale is most commonly 0 to 10, with 0 being "no pain or Itch or discomfort" and 10 being "the worst imaginable pain or Itch or discomfort"., Baseline, Week 16 and 28|Number of Participants Achieving Scalp Specific Physician's Global Assessment (PGA) Score, Scalp PGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening., Baseline, Week 16 and 28|Number of Participants Achieving Nail Specific PGA Score, The nail specific PGA is used to evaluate the current status of a participant's nail psoriasis on a scale of 0 to 4 (clear \[0\], minimal \[1\], mild \[2\], moderate \[3\], or severe \[4\])., Baseline, Week 16 and 28|Number of Participants Achieving Palmoplantar PGA Score, The PGA is a widely used outcome measure that relies on physician visual assessment of disease severity. The PGA determines psoriasis severity at a single point in time, without taking the baseline disease condition into clear (0), almost clear (1), mild (2), moderate (3), severe (4)., Baseline, Week 16 and 28|Number of Participants with Psoriasis (PSO) on Family and Partners by Family PSO Questionnaire, PSO is a self-administered questionnaire designed to address impact of PSO on family and partners by Family PSO questionnaire. Family PSO is a self-administrated questionnaire to assess the burden on partners of patients with psoriasis. The questionnaire has 15 items divided into five factors: (1) perceived strain by social reactions to the partner's psoriasis; (2) strain caused by cleaning; (3) acute emotional strain attributed directly to the psoriasis; (4) restrictions of social life; and (5) general emotional strain. The items are scaled in a 5-point Likert format: 0='not true', 1='somewhat true', 2='moderately true', 3='quite true', 4='very true', with the supplementary option 'does not apply to me'., Baseline, Week 16 and 28|Number of Participants with Psoriasis Treatment on Physician's Satisfaction, Baseline, Week 28|Hospital Anxiety and Depression Scales (HADS) Questionnaire, The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A score between 0 and 7 is 'normal', between 8 and 10 shows "light" level, between 11 and 14 "moderate" level, and between 15 and 21 "severe" level of anxiety/depression., Baseline, Week 16 and 28|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), FACIT-F is a questionnaire-based tool (FACIT-F, Vision 4) used to measure fatigue in patients. It consists of multiple items, each focusing on a different aspect of fatigue. The items are typically rated on a scale from 0 to 4, with 0 representing "not at all" and 4 representing "very much". Example items include: "I feel tired" or "I'm too tired to working". Higher scores indicate less fatigue., Baseline, Week 16 and 28|Correlations Between the Aforementioned Parameters, in Particular WHO-5 and HADS, To determine the correlation between the aforementioned parameters, in particular WHO-5 and HADS. Correlations between parameters are tested by the non-parametric Spearman test. In case of significant correlations, and if the nature of the data allows it, the conduct of more advanced regression analyses is permissible., Baseline, Week 16 and 28|Correlations Between the Aforementioned Parameters, in Particular WHO-5 and FACIT-F, To determine the correlation between the aforementioned parameters, in particular WHO-5 and FACIT-F. Correlations between parameters are tested by the non-parametric Spearman test. In case of significant correlations, and if the nature of the data allows it, the conduct of more advanced regression analyses is permissible., Baseline, Week 16 and 28