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

NCT07582783 | Recruiting

• 1 other identifier: CNTO1959PSO4036
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 19

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.

Conditions

Psoriasis

Outcome Measures

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.

  Up to 2 years

Secondary Outcomes (15)

• 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 PASI 90 Response Score

  At Weeks 0, 12, 24, 52 and 104

• Percentage of Participants Achieving PASI 75 Response Score

  At Weeks 0, 12, 24, 52 and 104

• Percentage of Participants Achieving PASI 100 Response Score

  At Weeks 0, 12, 24, 52 and 104

• Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1

  At Weeks 0, 12, 24, 52 and 104

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (19)

Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie

Bârlad, 731139, Romania

RECRUITING

Qualimed SRL

Brasov, 500073, Romania

RECRUITING

Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie

Bucharest, 011461, Romania

RECRUITING

Spitalul Clinic Colentina 1

Bucharest, 020125, Romania

RECRUITING

Spitalul Clinic Colentina

Bucharest, 020125, Romania

RECRUITING

Alin Nicolescu Medic Primar Dermato Venerologie

Bucharest, 030167, Romania

RECRUITING

OptiDerm Estet

Bucharest, 111870, Romania

RECRUITING

Spitalul Clinic Judetean de Urgenta Cluj Napoca

Cluj-Napoca, 400006, Romania

RECRUITING

Ambulator Specialitate Sp Militar de Urgenta Dr Constantin Papilian Cluj Napoca

Cluj-Napoca, 400132, Romania

RECRUITING

Innovative Derm SRL

Constanța, 900562, Romania

RECRUITING

Policlinica Dr.Corbeanu

Craiova, 200157, Romania

RECRUITING

Policlinica Top Med Buna Vestire

Craiova, 200330, Romania

RECRUITING

Derma Lux SRL

Iași, 700126, Romania

RECRUITING

Spitalul Clinic Judetean de Urgenta Bihor

Oradea, 410167, Romania

RECRUITING

Derma Lux SRL 1

Reghin, 545300, Romania

RECRUITING

Evaderm Health SRL

Slatina, 230086, Romania

RECRUITING

Spitalul Judetean de Urgenta 'Sf.Ioan cel Nou', Sectia Oncologie

Suceava, 720224, Romania

RECRUITING

Clinica Cabimed

Targu Mureș, 540119, Romania

RECRUITING

Dr Tirziu Dermato Chirurgie SRL

Timișoara, 300188, Romania

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Johnson & Johnson Romania SRL Clinical Trial

  Johnson & Johnson Romania SRL

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): November 10, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

RO (19)