Clinical trial NCT06142357: Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis
Official title: Prospective Observational Study With Retrospective Part to Evaluate Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Moderate-to-severe Plaque Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate-to-severe Plaque Psoriasis
Keywords: Secukinumab,
psoriasis,
pediatric patients,
NIS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients aged ≥6 to \<18 years old with moderate-to-severe plaque psoriasis after failure/intolerance of frontline treatment in routine clinical practice.

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 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.

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.

Primary outcomes:
measure: Drug survival rate of secukinumab
timeFrame: 52 weeks
Secondary outcomes:
measure: Secukinumab survival rates
timeFrame: Week 24, week 52, and week 104 after the index date
measure: Time to treatment discontinuation due to ineffectiveness
timeFrame: Week 12, week 24, week 52, week 104
measure: Proportion of patients achieving PASI 75 responses
timeFrame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
measure: Proportion of patients achieving PASI 90 responses
timeFrame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
measure: Proportion of patients achieving PASI 100 responses
timeFrame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
measure: Proportion of patients achieving a physicians' global assessment (PGA) 0/1 response
timeFrame: Baseline (study inclusion), week 24, week 52, and week 104 after the index date
measure: Adverse events (AEs) of special interest
timeFrame: Week 12, week 24, week 52, week 104 after the index date
measure: Proportion of patients discontinued secukinumab by reason
timeFrame: Week 12, week 24, week 52 and week 104
measure: Drug survival rate
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Grozny
country: Russian Federation
facility: Novartis Investigative Site
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Mytishchi
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov On Don
country: Russian Federation
facility: Novartis Investigative Site
city: Tula
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Yakutsk
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: