Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Secukinumab.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa, Pediatric Plaque Psoriasis, Juvenile Idiopathic Arthritis. Basic parameters: 6 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Regulatory Post-Marketing Surveillance to Assess Safety and Effectiveness in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea : a rPMS Study
Overview
Regulatory Post-Marketing Surveillance in hidradenitis suppurativa, pediatric plaque psoriasis and JIA treated with Cosentyx®(secukinumab) in Korea
Detailed description
This post-marketing study is a multicenter, single-arm, prospective, observational study.
Cosentyx is prescribed within the scope of the approved indications for hidradenitis suppurativa, pediatric plaque psoriasis, enthesitis-related arthritis and juvenile psoriatic arthritis in the juvenile idiopathic arthritis category. The decision to treat patients with the drug will be made within current clinical practice and will be clearly distinguished from the decision to include patients in this investigation. No additional diagnostics or monitoring will be performed for this study beyond what is typically performed in clinical practice.
Interventions
- Drug Secukinumab
This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Primary outcome measures
- Number of participants having Adverse Events (AEs) and Serious Adverse Events (SAEs) within each indication [Time frame: Up to 24 weeks]
Secondary outcome measures (12)
- Proportion of paticipants achieving 50% reduction in hidradenitis suppurativa clinical response (HiSCR50) - HS participants [Time frame: 12 and 24 weeks]
- Proportion of participants achieving a severity of 0 or 1 on the hidradenitis supurativa-physician's global assessment (HS-PGA) - HS participants [Time frame: 12 and 24 weeks]
- Proportion of participants with a 55% or greater reduction in international hidradenitis suppurativa severity scoring system (IHS4-55) - HS participants [Time frame: 12 and 24 weeks]
- Proportion of participants with a ≥30% reduction in Hidradenitis suppurativa-related skin pain numerical rating scale (NRS) - HS participants [Time frame: 12 and 24 weeks]
- Proportion of participants with an Hidradenitis supurativa flare - HS participants [Time frame: 12 and 24 weeks]
- Proportion of participants by Hurley stage - HS participants [Time frame: 12 and 24 weeks]
- Change from baseline in Psoriasis Area and Severity Index (PASI) - Pediatric plaque psoriasis participants [Time frame: 12 and 24 weeks]
- Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 - Pediatric plaque psoriasis participants [Time frame: 12 and 24 weeks]
- Change from baseline in active joints by Tender Joint Count (TJC) - JIA participants [Time frame: 12 and 24 weeks]
- Change from baseline in active joints by swollen joint count (SJC)- JIA participants [Time frame: 12 and 24 weeks]
- Change from baseline in clinical juvenile arthritis disease activity score (cJADAS) - JIA participants [Time frame: 12 and 24 weeks]
- Physician evaluation of participant symptoms [Time frame: 12 and 24 weeks]
Eligibility criteria
Inclusion criteria
Hidradenitis suppurativa:
- Adults 18 years of age and older with moderate to severe hidradenitis suppurativa who are or will be receiving Cosentyx within the scope of approved indication.
- Patients who have agreed to participate in study (written informed consent)
Pediatric plaque psoriasis:
- Patients with moderate to severe plaque psoriasis between the ages of 6 and 18 years who are receiving or will receive Cosentyx within the scope of approved indication.
- Patients with patient or guardian consent to participate in study (written informed consent)
Juvenile idiopathic arthritis:
- Enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category patients with enthesitis related arthritis and juvenile psoriatic arthritis in juvenile idiopathic arthritis category between the ages of 6 and 18 years and are receiving or will receive Cosentyx within the scope of approved indication.
- Patients with patient or guardian consent to participate in study (written informed consent)
Exclusion criteria
- Patients who are contraindicated according to national prescribing information
- Patients participating in other interventional clinical trials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Novartis Investigative Site — Seoul
Identifiers
NCT: NCT07243782 · CAIN457MKR01