A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania
Recruiting · NCT07582783 · Observational (researchers observe without assigning treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
19 locations listed.
- Qualimed SRL - Brasov, Romania
- Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie - Bucharest, Romania
- Spitalul Clinic Colentina 1 - Bucharest, Romania
- Spitalul Clinic Colentina - Bucharest, Romania
- Alin Nicolescu Medic Primar Dermato Venerologie - Bucharest, Romania
- OptiDerm Estet - Bucharest, Romania
- Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie - Bârlad, Romania
- Spitalul Clinic Judetean de Urgenta Cluj Napoca - Cluj-Napoca, Romania
- Ambulator Specialitate Sp Militar de Urgenta Dr Constantin Papilian Cluj Napoca - Cluj-Napoca, Romania
- Innovative Derm SRL - Constanța, Romania
- Policlinica Dr.Corbeanu - Craiova, Romania
- Policlinica Top Med Buna Vestire - Craiova, Romania
- Derma Lux SRL - Iași, Romania
- Spitalul Clinic Judetean de Urgenta Bihor - Oradea, Romania
- Derma Lux SRL 1 - Reghin, Romania
- Evaderm Health SRL - Slatina, Romania
- Spitalul Judetean de Urgenta 'Sf.Ioan cel Nou', Sectia Oncologie - Suceava, Romania
- Clinica Cabimed - Targu Mureș, Romania
- Dr Tirziu Dermato Chirurgie SRL - Timișoara, Romania