Last Update: Apr 10, 2024
Prospective Observational Study With Retrospective Part to Evaluate Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Moderate-to-severe Plaque Psoriasis
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAIN457LRU01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Moderate-to-severe Plaque Psoriasis
Recruiting
200
Dec 29, 2023
Jul 31, 2027
All
6 Years - 18 Years (Child, Adult)

Interventions

Other

Secukinumab

There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled

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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