Persistence on Guselkumab in Romanian adults with moderate-to-severe plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with moderate-to-severe plaque psoriasis who start guselkumab to see how long they stay on the treatment over a two-year period. It collects patient-reported outcomes and outlines requirements such as informed consent and language-compliant PRO completion. Participants must be bio-naive to guselkumab and meet local regulatory criteria, with exclusion for pregnancy, recent interventional studies, or current Johnson & Johnson-sponsored observational studies. No specific intervention beyond routine guselkumab treatment is described, and sites are located in several Romanian clinics and hospitals. The lead sponsor is Janssen Research & Development, LLC, with collaboration listed as none.

Why it matters

Who can join: the full rules

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's running

• Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie
  Bârlad, Romania Recruiting
• 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

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

• Higher-dose, less-frequent guselkumab versus the usual dose for moderate-to-severe plaque psoriasis in Chinese adults

  This will test whether a higher dose given less often of guselkumab works as well and is as safe as the usual dosing for Chinese adults with moderate-to-severe plaque psoriasis.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07532486

• Adjusting guselkumab dosing schedules for adults with plaque psoriasis

  This project will see if adults with plaque psoriasis who are doing well on guselkumab can safely have their injections spaced farther apart than nine weeks.

  Recruiting Centre Hospitalier Universitaire de Nice · Nice, Alpes Maritimes · NCT07430319

• HB0017 Injection safety and PK in low-weight adults at different injection sites

  This early-phase study tests a single subcutaneous HB0017 injection in healthy, low-weight adults and compares how the body processes the drug when injected at different sites.

  Recruiting Phase 1 Huabo Biopharm Co., Ltd. · Hangzhou, Zhejiang · NCT07920861

• MK-8644: first-in-human test in healthy people and people with psoriasis

  This early-phase study tests MK-8644 versus placebo in healthy volunteers and people with psoriasis to see if it is safe and tolerable.

  Recruiting Phase 1 Merck Sharp & Dohme LLC · Melbourne, Victoria · NCT07850310

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

  This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen Research & Development, LLC · Amiens · NCT07822529

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.