Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis

Launched by NOVARTIS PHARMACEUTICALS · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called secukinumab in treating children and teenagers with specific types of arthritis known as juvenile enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (jPsA). The goal is to understand how well this treatment works in young patients who are experiencing active symptoms of these conditions. The study will involve multiple centers but is not yet recruiting participants.

To be eligible for the trial, participants must be between 6 and 17 years old and have a doctor’s diagnosis of active ERA or jPsA. They should also have been prescribed secukinumab by their doctor within the past 4 to 8 weeks. Before starting the treatment, participants will need to undergo certain tests to ensure they are safe to receive secukinumab. Throughout the study, participants can expect regular check-ups and health assessments to monitor their response to the treatment and any side effects. It's important to note that some individuals, such as those with certain infections or other specific health conditions, may not be eligible to participate.

Gender

ALL

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).