Not Yet RecruitingNot Applicable

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

150 participantsStarted 2025-04-30

Plain-language summary

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

Age range6 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.
✕. Age \<6 years or ≥18 years.
✕. 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.

Drug survival rate

Timeframe: 24 months

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

Clinical remission/inactive disease rates by Wallace criteria

Timeframe: Month 3, Month 6, Month 12, Month 18, and Month 24

NCT IDNCT06431750

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-08-30

Novartis Pharmaceuticals

Who can participate

Age range6 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.
✕. Age \<6 years or ≥18 years.
✕. 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.

What they're measuring

Drug survival rate

Timeframe: 24 months

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

Clinical remission/inactive disease rates by Wallace criteria

Timeframe: Month 3, Month 6, Month 12, Month 18, and Month 24