Study Description
Multicenter, non-interventional, cohort study in pediatric patients with moderate to
severe plaque-type psoriasis. Retrospective data collection is planned at patients'
inclusion. 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 moderate-to-severe plaque psoriasis for whom routine treatment
with secukinumab according to the approved national label is initiated during 4 to 16
weeks Retrospective data collection is planned at patients' inclusion. Prospective data
collection will continue during follow-up routine visits until secukinumab
discontinuation or maximum duration of follow-up for 104 weeks after index date.
Interventions
Secukinumab
Eligibility Criteria
Inclusion Criteria:
1. Written informed consent and legal representative's permission for study
participation obtained prior to beginning of participation in the study.
2. Age ≥6 to <18 years old.
3. 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.
4. Failure or intolerance of prior psoriasis treatment.
5. Patient was prescribed with secukinumab within 4-16 weeks before inclusion.
6. 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 Criteria:
1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients,
or injection device components (i.e., latex).
2. History of chronic recurrent infection.
3. Clinically significant infection exacerbation, including active tuberculosis.
4. Age <6 years or ≥18 years.
5. Pregnancy and breastfeeding.
6. Patients participating in parallel in an interventional clinical trial.
7. Patients participating in parallel in other Novartis-sponsored non-interventional
study generating primary data for secukinumab.
8. Patients within the safety follow-up phase of interventional study.
9. Active inflammatory bowel disease at inclusion.
10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
11. Any medical or psychological condition in the investigator's opinion which may
prevent the study participation.
Novartis Investigative Site
Recruiting
Rostov On Don,344022,Russian Federation
Novartis Investigative Site
Recruiting
Kemerovo,650025,Russian Federation
Novartis Investigative Site
Recruiting
Saint-Petersburg,194100,Russian Federation
Novartis Investigative Site
Recruiting
Moscow,119296,Russian Federation
Novartis Investigative Site
Recruiting
Tula,300053,Russian Federation
Novartis Investigative Site
Recruiting
Moscow,119435,Russian Federation
Novartis Investigative Site
Recruiting
Chelyabinsk,454048,Russian Federation
Novartis Investigative Site
Recruiting
Yakutsk,677000,Russian Federation
Novartis Investigative Site
Recruiting
Moscow,119571,Russian Federation
Novartis Investigative Site
Recruiting
Grozny,364022,Russian Federation
Novartis Investigative Site
Recruiting
Mytishchi,141009,Russian Federation
Novartis Investigative Site
Recruiting
Izhevsk,426009,Russian Federation
Novartis Investigative Site
Recruiting
Nizhny Novgorod,603066,Russian Federation
Novartis Investigative Site
Recruiting
Kazan,420012,Russian Federation
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