About this trial
This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a confirmed diagnosis of moderate-to-severe plaque psoriasis
Participant must sign an informed consent form allowing source data verification in accordance with local requirements
Is able to read, understand, and complete the patient reported outcomes (PRO) instruments in local language and comply with completion of all PRO instruments
No previous exposure to biological treatment, including guselkumab (bio-naive patient)
Disqualifiers
Meets any of the contraindications according to the latest version of the locally approved summary of product characteristics (SmPC)
Is pregnant or lactating
Current or recent (in the last 30 days prior to first SC dose of guselkumab) participation in any interventional study with investigational product.
Currently enrolled in another observational study sponsored or managed by a Johnson & Johnson company
Trial population
Participants with moderate-to-severe plaque psoriasis, in accordance with clinical practice in Romania, who have never been treated with biological treatment before will be observed.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Time to Guselkumab Discontinuation Throughout 2 Years
Time to guselkumab discontinuation is defined as the time (days) from the date of the first guselkumab administration to the date of the last administered dose preceding permanent cessation.
Secondary outcomes
Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Scores Among Participants Remaining on Treatment
Percentage of participants achieving absolute PASI scores less than or equal to (\<=) 1, 2, 3 and 5, and PASI = 0 among participants remaining on treatment will be reported. In the PASI system, the body is divided into 4 areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that range from 0 to 6, and for erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating more severe psoriasis.
Percentage of Participants Achieving PASI 90 Response Score
PASI 90 response is defined as greater than or equal to (\>=) 90 percent (%) improvement in PASI score from baseline. In the PASI system, the body is divided into 4 areas: the head, trunk, upper extremities and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that range from 0 to 6, and for erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating more severe psoriasis.
Percentage of Participants Achieving PASI 75 Response Score
PASI 75 response is defined as \>= 75% improvement in PASI score from baseline. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.
Percentage of Participants Achieving PASI 100 Response Score
PASI 100 response is defined as \>= 100% improvement in PASI score from baseline. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.
Sponsors and contacts
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