RECRUITINGOBSERVATIONAL
A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
A Non-interventional, Multi-centric, Single Country Observational Study to Assess the Safety and Effectiveness of Guselkumab After Ustekinumab (Originator or Biosimilar) in Moderate to Severe Psoriasis Patients in Clinical Routine
About This Trial
The purpose of this study is to assess the effectiveness and safety of guselkumab following a switch from ustekinumab or an ustekinumab biosimilar in participants with moderate to severe psoriasis, a chronic inflammatory skin disease characterized by erythematous, scaly plaques that may be associated with pain and pruritus, in routine clinical practice.
Who May Be Eligible (Plain English)
Who May Qualify:
- Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment
- Participants who are currently treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab
- Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab
- Participants must understand and be willing and able to answer patient-reported outcomes (PROs)
- Must sign an willing to sign a consent form form (ICF) allowing data collection and source data verification in accordance with local requirements
Who Should NOT Join This Trial:
- Contraindication or hypersensitivity to Guselkumab or any ingredient in the injection solution/liquid
- Pregnancy or breastfeeding
- Currently enrolled in an interventional study
- Currently enrolled in an observational study sponsored or managed by a Janssen company
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion criteria:
* Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment
* Participants who are currently treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab
* Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab
* Participants must understand and be willing and able to answer patient-reported outcomes (PROs)
* Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion criteria:
* Contraindication or hypersensitivity to Guselkumab or any ingredient in the injection solution/liquid
* Pregnancy or breastfeeding
* Currently enrolled in an interventional study
* Currently enrolled in an observational study sponsored or managed by a Janssen company
Locations (1)
LKH-Univ. Klinikum Graz
Graz, Austria