A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania

Janssen Research & Development, LLC200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Psoriasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie

Bârlad, Romania

RECRUITING

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.

Time frame: Up to 2 years

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.

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.

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

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Qualimed SRL

Brasov, Romania

RECRUITING

Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie

Bucharest, Romania

RECRUITING

Spitalul Clinic Colentina 1

Bucharest, Romania

RECRUITING

Spitalul Clinic Colentina

Bucharest, Romania

RECRUITING

Alin Nicolescu Medic Primar Dermato Venerologie

Bucharest, Romania

RECRUITING

OptiDerm Estet

Bucharest, Romania

RECRUITING

Spitalul Clinic Judetean de Urgenta Cluj Napoca

Cluj-Napoca, Romania

RECRUITING

Ambulator Specialitate Sp Militar de Urgenta Dr Constantin Papilian Cluj Napoca

Cluj-Napoca, Romania

RECRUITING

Innovative Derm SRL

Constanța, Romania

RECRUITING

...and 9 more locations

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

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