Psoriasis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Intended for the treatment with guselkumab according to the approved indication
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Guselkumab Discontinuation Throughout 2 Years | Up to 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Scores Among Participants Remaining on Treatment | At Weeks 12, 24, 52 and 104 | 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 | At Weeks 0, 12, 24, 52 and 104 | 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 | At Weeks 0, 12, 24, 52 and 104 | 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 | At Weeks 0, 12, 24, 52 and 104 | 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. |
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 | At Weeks 0, 12, 24, 52 and 104 | 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. |
| Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | At Weeks 0, 12, 24, 52 and 104 | 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. |
| Percentage of Participants Achieving IGA Score of 0 | At Weeks 0, 12, 24, 52 and 104 | 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. |
| Participant Baseline Characteristics: Age | Baseline | Participant's age at the time of starting guselkumab treatment will be reported. |
| Participant Baseline Characteristics: Gender | Baseline | Gender (male, female) of participants at the time of starting guselkumab treatment will be reported. |
| Participant Baseline Characteristics: Height | Baseline | Height of participants at the time of starting guselkumab treatment will be reported. |
| Participant Baseline Characteristics: Weight | Baseline | Weight of participants at the time of starting guselkumab treatment will be reported. |
| Number of Participants Reporting Disease Severity | Baseline | Number of participants with disease severity will be reported. |
| Number of Participants Reporting Smoking History and Alcohol Use | Baseline | Number of participants reporting smoking history and alcohol use will be reported. |
| Hazard Ratio Between Baseline Factors and Time to Guselkumab Treatment Discontinuation | Up to Week 104 | Hazard Ratio Between Baseline Factors and time to Guselkumab treatment discontinuation will be reported. |
| Number of Participants with Adverse Events (AEs) | Up to Week 104 | 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. |
Countries
Romania
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Romania SRL Clinical Trial
Johnson & Johnson Romania SRL
Outcome results
None listed