NCT07449234
Recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Janssen-Cilag Ltd.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 3 after Switching to Guselkumab at Week 28
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Guselkumab: Switch from Ustekinumab
Participants with moderate-to-severe psoriasis who are candidates for systemic treatment (according to the Guselkumab label) and who are medically indicated to switch from Ustekinumab or its biosimilar to Guselkumab can be included in this study. Only data available per clinical practice will be collected within this study.
Outcomes
Primary Outcomes
Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 3 after Switching to Guselkumab at Week 28
Time Frame: At Week 28
The PASI is a standardized scoring method for assessing and grading the severity of a participant's psoriasis. PASI yields a numeric score ranging from 0 (skin completely free of symptoms) to 72 (maximum expression of psoriasis), with higher scores indicating more severe psoriasis.
Secondary Outcomes
- Percentage of Participants Achieving a PASI Score <= 3 after Switching to Guselkumab at Weeks 12 and 52(At Weeks 12 and 52)
- Percentage of Participants Achieving a Greater Than or Equal to (>=) 90 Percent (%) Improvement in PASI Score (PASI 90) from Baseline at Weeks 12, 28 and 52(At Weeks 12, 28 and 52)
- Percentage of Participants Achieving 100% Improvement in PASI Score (PASI 100) from Baseline at Weeks 12, 28 and 52(At Weeks 12, 28 and 52)
- Number of Participants with Absolute PASI Course from Baseline to Week 52(Baseline up to Week 52)
- Absolute Change from Baseline In PASI Scores at Week 52(Baseline up to Week 52)
- Relative Change from Baseline In PASI Score at Week 52(Baseline up to Week 52)
- Absolute Change from Baseline in Body Surface Area (BSA) Score at Week 52(Baseline up to Week 52)
- Relative Change from Baseline in BSA Score at Week 52(Baseline up to Week 52)
- Absolute Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 52(Baseline up to Week 52)
- Relative Change from Baseline in DLQI Score at Week 52(Baseline up to Week 52)
- Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 12, 28, and 52(At Weeks 12, 28 and 52)
- Clinical Characteristics: Time Since Psoriasis Diagnosis(Baseline up to Week 52)
- Absolute Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index Questionnaire Score at Week 52(Baseline up to Week 52)
- Relative Change from Baseline in WHO-5 Well-Being Index Questionnaire Score at Week 52(Baseline up to Week 52)
- Absolute Change From Baseline in Worst Itch Numeric Rating Scores (WI-NRS) at Week 52(Baseline up to Week 52)
- Relative Change from Baseline in WI-NRS at Week 52(Baseline up to Week 52)
- Percentage of Participants Achieving Palmoplantar PGA Score of 0 at Weeks 12, 28, and 52(At Weeks 12, 28 and 52)
- Absolute Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI: PSO) Scores at Week 52(Baseline up to Week 52)
- Relative Change from Baseline in WPAI:PSO Scores at Week 52(Baseline up to Week 52)
- Absolute Change from Baseline in Anogenital Physician's Global Assessment (PGA) Score at Week 52(Baseline up to Week 52)
- Percentage of Participants Achieving Anogenital PGA Score of 0 at Weeks 12, 28, and 52(At Weeks 12, 28 and 52)
- Absolute Change from Baseline in Palmoplantar PGA Score at Week 52(Baseline up to Week 52)
- Absolute Change from Baseline in Scalp PGA Score at Week 52(Baseline up to Week 52)
- Percentage of Participants Achieving Scalp PGA Score of 0 at Weeks 12, 28, and 52(At Weeks 12, 28 and 52)
- Absolute Change from Baseline in Scalp Itch Numeric Rating Scales (NRS) at Week 52(Baseline up to Week 52)
- Relative Change from Baseline in Scalp Itch NRS at Week 52(Baseline up to Week 52)
- Demographic Characteristics: Height(Baseline)
- Relative Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 52(Baseline up to Week 52)
- Percentage of Participants Achieving NAPSI Score of 0 at Weeks 12, 28, and 52(At Weeks 12, 28 and 52)
- Demographic Characteristics: Age(Baseline)
- Demographic Characteristics: Sex(Baseline)
- Demographic Characteristics: Weight(Baseline)
- Clinical Characteristics: Prior Treatments for Moderate to Severe Psoriasis(Baseline)
- Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab(Baseline)
- Treatment Patterns: Dose of the Treatment(Up to Week 52)
- Treatment Patterns: Frequency of the Treatment(Up to Week 52)
- Number of Participants with Specific Psoriatic Comorbidities(Baseline)
- Number of Participants with Other Comorbidities(Baseline)
- Number of Participants Receiving Concomitant Medications for Specific Psoriatic Comorbidities(Up to Week 52)
Investigators
Study Sites (1)
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