Clinical trial NCT06431750: Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis
Official title: Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Juvenile Idiopathic Arthritis
Keywords: Juvenile Idiopathic Arthritis
JIA
Secukinumab
Cosentyx
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-05-29
Enrollment: 150
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 with active ERA/jPsA for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 8 weeks prior to enrollment

Brief summary: This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis

Detailed description: Rheumatologists and pediatricians actively managing pediatric Enthesitis-related Arthritis (ERA) and Juvenile Psoriatic Arthritis (jPsA) in different regions of Russia are planned to participate in the study. To be include in this study, physicians must consult more than 10 pediatric patients with ERA/jPsA in a typical month. Any pediatric patients with active ERA/jPsA who started secukinumab treatment (index date) within 4-8 weeks prior to inclusion can be enrolled. At the inclusion retrospective data collection is planned, then data will be collected 3 months of treatment), 6, 12, 18, and 24 months after index date. Therefore, maximum duration of prospective observation is expected to be 23 months. Data collection schedule fits routine (Juvenile Idiopathic Arthritis) JIA management guidelines for patients receiving biologics stating that treatment effectiveness should be evaluated at 3 and 6 months after biologic initiation and every 6 months thereafter. At each visit effectiveness and tolerability parameters, as well as the patients' Quality of life (QoL) will be documented. Retrospective data will be collected for medical history and JIA treatment, including secukinumab before inclusion, as well to describe all necessary parameters since the Index date. Expected look-back period is 12 months.

Initiation of secukinumab treatment will be considered the 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. Recognized physician diagnosis of active ERA or jPsA:

   * ERA per ILAR criteria:

     * Peripheral arthritis and enthesitis, or
     * Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or
     * Arthritis or enthesitis plus 2 of the following: sacroiliac joint tenderness; inflammatory back pain; presence of HLA-B27 antigen; acute (symptomatic) anterior uveitis; and history of a spondyloarthritis in a first-degree relative.
   * jPsA per ILAR criteria

     * Arthritis and psoriasis, or
     * arthritis and at least 2 of the following:

       * Dactylitis
       * Nail pitting or onycholysis
       * Psoriasis in a first-degree relative.
4. Patient was prescribed with secukinumab within 4-8 weeks before inclusion.
5. 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.
6. The Purified Protein Derivative (PPD) Skin Test for Tuberculosis and/or Negative T-SPOT test and/or TB-feron test before secukinumab treatment and every 6 months.

Exclusion Criteria:

1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
2. Chronic recurrent infections.
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.
12. Concomitant conditions (Candida infections, other infections, inflammatory bowel disease \[IBD\], uveitis, skin and nail psoriasis for ERA patients, hepatitis B, hepatitis C, tuberculosis).

Primary outcomes:
measure: Drug survival rate
timeFrame: 24 months
measure: American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90 achievement rates
timeFrame: Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Clinical remission/inactive disease rates by Wallace criteria
timeFrame: Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary outcomes:
measure: Childhood Health Assessment Questionnaire (CHAQ) score
timeFrame: Up to 24 months
measure: Physician global assessment of disease activity
timeFrame: Up to 24 months
measure: Patient/legal representative global assessment of disease activity
timeFrame: Up to 24 months
measure: Time to treatment failure
timeFrame: Up to 24 months
measure: Proportion of patients not achieving ACR Pedi 30 response
timeFrame: Month 3
measure: Disease activity index in 71 joints Juvenile Arthritis Disease Activity Score (JADAS71)
timeFrame: Up to 24 months
measure: Juvenile Spondyloarthritis (JSpA) Disease Activity - JSpADA
timeFrame: Up to 24 months
measure: Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA)
timeFrame: Up to 24 months
measure: Number of participants by reasons of secukinumab discontinuation
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: