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

Korábbi kezelés

• Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
• Concomitant conditions (Candida infections, other infections, inflammatory bowel disease [IBD], uveitis, skin and nail psoriasis for ERA patients, hepatitis B, hepatitis C, tuberculosis).

Más betegség

• Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
• Chronic recurrent infections.
• Clinically significant infection exacerbation, including active tuberculosis.
• Active inflammatory bowel disease at inclusion.
• Any medical or psychological condition in the investigator's opinion which may prevent the study participation.

Életkor

• Age <6 years or ≥18 years.

Egyéb

• Pregnancy and breastfeeding.
• Patients participating in parallel in an interventional clinical trial.
• Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.
• Patients within the safety follow-up phase of interventional study.

• Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.
• Age ≥6 to <18 years old.
• 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.
• Patient was prescribed with secukinumab within 4-8 weeks before inclusion.
• 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.
• 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.