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

ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Group 1: Participants with Moderate-to-Severe Plaque Psoriasis

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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