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NCT06142357 | RECRUITING | Moderate-to-severe Plaque Psoriasis

Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis
Sponsor:

Novartis Pharmaceuticals

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.

Condition or disease

Moderate-to-severe Plaque Psoriasis

Intervention/treatment

Secukinumab

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
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
Actual Study Start Date : 2023-12-29
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2027-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis

Location Details

NCT06142357

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Locations

RECRUITING

Russian Federation,

Novartis Investigative Site

Chellyabinsk, Russian Federation, 454048

RECRUITING

Russian Federation,

Novartis Investigative Site

Grozny, Russian Federation, 364022

RECRUITING

Russian Federation,

Novartis Investigative Site

Izhevsk, Russian Federation, 426009

RECRUITING

Russian Federation,

Novartis Investigative Site

Kazan, Russian Federation, 420012

RECRUITING

Russian Federation,

Novartis Investigative Site

Kemerovo, Russian Federation, 650025

RECRUITING

Russian Federation,

Novartis Investigative Site

Moscow, Russian Federation, 105007

RECRUITING

Russian Federation,

Novartis Investigative Site

Moscow, Russian Federation, 117513

RECRUITING

Russian Federation,

Novartis Investigative Site

Moscow, Russian Federation, 119296

RECRUITING

Russian Federation,

Novartis Investigative Site

Moscow, Russian Federation, 119435

RECRUITING

Russian Federation,

Novartis Investigative Site

Mytishchi, Russian Federation, 141009

RECRUITING

Russian Federation,

Novartis Investigative Site

Nizhniy Novgorod, Russian Federation, 603950

RECRUITING

Russian Federation,

Novartis Investigative Site

Rostov On Don, Russian Federation, 344022

RECRUITING

Russian Federation,

Novartis Investigative Site

Tula, Russian Federation, 300053

RECRUITING

Russian Federation,

Novartis Investigative Site

Ufa, Russian Federation, 450000

RECRUITING

Russian Federation,

Novartis Investigative Site

Yakutsk, Russian Federation, 677000