Status:
ACTIVE_NOT_RECRUITING
Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Moderate-to-severe Plaque Psoriasis
Eligibility:
All Genders
6-18 years
Brief Summary
Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.
Detailed Description
This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with modera...
Eligibility Criteria
Inclusion
- Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
- Age ≥6 to \<18 years old.
- Established diagnosis of active moderate-to-severe plaque psoriasis defined as a PASI score ≥ 10, body surface area (BSA) involvement of ≥10% and PGA score ≥ 3 only or with concomitant psoriatic arthritis.
- Failure or intolerance of prior psoriasis treatment.
- Patient was prescribed with secukinumab within 4-16 weeks before inclusion.
- Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct.
Exclusion
- Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
- History of chronic recurrent infection.
- Clinically significant infection exacerbation, including active tuberculosis.
- Age \<6 years or ≥18 years.
- Pregnancy and breastfeeding.
- Patients participating in parallel in an interventional clinical trial.
- Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.
- Patients within the safety follow-up phase of interventional study.
- Active inflammatory bowel disease at inclusion.
- Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
- Any medical or psychological condition in the investigator's opinion which may prevent the study participation.
Key Trial Info
Start Date :
December 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2027
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT06142357
Start Date
December 29 2023
End Date
August 31 2027
Last Update
December 24 2025
Active Locations (16)
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1
Novartis Investigative Site
Chelyabinsk, Russia, 454048
2
Novartis Investigative Site
Grozny, Russia, 364022
3
Novartis Investigative Site
Izhevsk, Russia, 426009
4
Novartis Investigative Site
Kazan', Russia, 420012