RecruitingRecruiting
A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania
NCT07582783 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Persistence to Treatment With Guselkumab in Bio-Naive Patients With Moderate-to-Severe Plaque Psoriasis: A Romanian Non-Interventional Multi-center Observational Study
About this study
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
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
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-05-15
Estimated completion: 2028-11-10
Last updated: 2026-07-06
Primary outcomes
- • Time to Guselkumab Discontinuation Throughout 2 Years (Up to 2 years)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJohnson & Johnson Romania SRL Clinical Trial · study_director, Johnson & Johnson Romania SRL
All locations (19)
Mihaila G. Georgiana - Cabinet Medical Individual DermatovenerologieRecruiting
Bârlad, Romania
Qualimed SRLRecruiting
Brasov, Romania
Spitalul Universitar de Urgenta Elias, Clinica de CardiologieRecruiting
Bucharest, Romania
Spitalul Clinic Colentina 1Recruiting
Bucharest, Romania
Spitalul Clinic ColentinaRecruiting
Bucharest, Romania
Alin Nicolescu Medic Primar Dermato VenerologieRecruiting
Bucharest, Romania
OptiDerm EstetRecruiting
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj NapocaRecruiting
Cluj-Napoca, Romania
Ambulator Specialitate Sp Militar de Urgenta Dr Constantin Papilian Cluj NapocaRecruiting
Cluj-Napoca, Romania
Innovative Derm SRLRecruiting
Constanța, Romania
Policlinica Dr.CorbeanuRecruiting
Craiova, Romania
Policlinica Top Med Buna VestireRecruiting
Craiova, Romania
Derma Lux SRLRecruiting
Iași, Romania
Spitalul Clinic Judetean de Urgenta BihorRecruiting
Oradea, Romania
Derma Lux SRL 1Recruiting
Reghin, Romania
Evaderm Health SRLRecruiting
Slatina, Romania
Spitalul Judetean de Urgenta 'Sf.Ioan cel Nou', Sectia OncologieRecruiting
Suceava, Romania
Clinica CabimedRecruiting
Targu Mureș, Romania
Dr Tirziu Dermato Chirurgie SRLRecruiting
Timișoara, Romania