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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Participants with Moderate-to-Severe Plaque Psoriasis | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Romania SRL Clinical Trial | Johnson & Johnson Romania SRL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie | Recruiting | Bârlad | 731139 | Romania | ||
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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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline |
| Participant Baseline Characteristics: Gender | Gender (male, female) of participants at the time of starting guselkumab treatment will be reported. | Baseline |
| Participant Baseline Characteristics: Height | Height of participants at the time of starting guselkumab treatment will be reported. | Baseline |
| Participant Baseline Characteristics: Weight | Weight of participants at the time of starting guselkumab treatment will be reported. | Baseline |
| Number of Participants Reporting Disease Severity | Number of participants with disease severity will be reported. | Baseline |
| Number of Participants Reporting Smoking History and Alcohol Use | Number of participants reporting smoking history and alcohol use will be reported. | 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. | 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. | Up to Week 104 |
| Qualimed SRL |
| Recruiting |
| Brasov |
| 500073 |
| Romania |
| Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie | Recruiting | Bucharest | 011461 | Romania |
| Spitalul Clinic Colentina 1 | Recruiting | Bucharest | 020125 | Romania |
| Spitalul Clinic Colentina | Recruiting | Bucharest | 020125 | Romania |
| Alin Nicolescu Medic Primar Dermato Venerologie | Recruiting | Bucharest | 030167 | Romania |
| OptiDerm Estet | Recruiting | Bucharest | 111870 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca | Recruiting | Cluj-Napoca | 400006 | Romania |
| Ambulator Specialitate Sp Militar de Urgenta Dr Constantin Papilian Cluj Napoca | Recruiting | Cluj-Napoca | 400132 | Romania |
| Innovative Derm SRL | Recruiting | Constanța | 900562 | Romania |
| Policlinica Dr.Corbeanu | Recruiting | Craiova | 200157 | Romania |
| Policlinica Top Med Buna Vestire | Recruiting | Craiova | 200330 | Romania |
| Derma Lux SRL | Recruiting | Iași | 700126 | Romania |
| Spitalul Clinic Judetean de Urgenta Bihor | Recruiting | Oradea | 410167 | Romania |
| Derma Lux SRL 1 | Recruiting | Reghin | 545300 | Romania |
| Evaderm Health SRL | Recruiting | Slatina | 230086 | Romania |
| Spitalul Judetean de Urgenta 'Sf.Ioan cel Nou', Sectia Oncologie | Recruiting | Suceava | 720224 | Romania |
| Clinica Cabimed | Recruiting | Targu Mureș | 540119 | Romania |
| Dr Tirziu Dermato Chirurgie SRL | Recruiting | Timișoara | 300188 | Romania |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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