An observational study in Psoriasis, sponsored by Janssen Research & Development, LLC. Recruiting at 19 sites in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Janssen Research & Development, LLC · Observational
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.
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.
Exclusion criteria:
Participants with confirmed diagnosis of moderate-to-severe plaque psoriasis who have never been treated with biological treatment before, and receiving guselkumab as per routine clinical practice will be enrolled. Only data available per clinical practice will be collected within this study. The primary data source for this study will be the medical records of each participant.
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.
Time frame: Up to 2 years
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.
Time frame: At Weeks 12, 24, 52 and 104
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.
Time frame: At Weeks 0, 12, 24, 52 and 104
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.
Time frame: At Weeks 0, 12, 24, 52 and 104
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.
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1
The DLQI is a 10-item questionnaire that can be used to assess overall quality-of-life and 6 different aspects that may affect quality-of-life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on quality-of-life.
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1
The IGA scale is a visual assessment that consists of a score ranging from 0 (clear) to 4 (severe). The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Skin rated as "4" is bright red in color with marked plaque elevation and is dominated by thick, non-tenacious scale. For treatment to be considered successful, the affected area must receive a score of 0 or 1 and experience a two-point improvement from baseline.
Time frame: At Weeks 0, 12, 24, 52 and 104
Percentage of Participants Achieving IGA Score of 0
The IGA scale is a visual assessment that consists of a score ranging from 0 (clear) to 4 (severe). The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Skin rated as "4" is bright red in color with marked plaque elevation and is dominated by thick, non-tenacious scale. For treatment to be considered successful, the affected area must receive a score of 0 or 1 and experience a two-point improvement from baseline.
Time frame: At Weeks 0, 12, 24, 52 and 104
Participant Baseline Characteristics: Age
Participant's age at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Participant Baseline Characteristics: Gender
Gender (male, female) of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Participant Baseline Characteristics: Height
Height of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Participant Baseline Characteristics: Weight
Weight of participants at the time of starting guselkumab treatment will be reported.
Time frame: Baseline
Number of Participants Reporting Disease Severity
Number of participants with disease severity will be reported.
Time frame: Baseline
Number of Participants Reporting Smoking History and Alcohol Use
Number of participants reporting smoking history and alcohol use will be reported.
Time frame: Baseline
Hazard Ratio Between Baseline Factors and Time to Guselkumab Treatment Discontinuation
Hazard Ratio Between Baseline Factors and time to Guselkumab treatment discontinuation will be reported.
Time frame: Up to Week 104
Number of Participants with Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Time frame: Up to Week 104
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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