An observational study in Psoriasis, sponsored by Janssen Research & Development, LLC. Recruiting at 20 sites in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · 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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 200 is close to the median of 199 across 407 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Sep 2028, 28 months after the start.
Of 81 industry-sponsored observational studies under Psoriasis, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 74. This study's planned 28 months is below that.
Counting every sponsor, half of 173 studies reached it within 37 months; a quarter within 23 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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