Can a biologic drug tame juvenile arthritis in kids?
NCT ID NCT06431750
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This study follows children aged 6 to 17 with active juvenile enthesitis-related or psoriatic arthritis who are being treated with secukinumab. Researchers will track how long children stay on the drug, how much their symptoms improve, and whether they achieve remission. The goal is to see how effective this treatment is in real-world settings, outside of a controlled trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Secukinumab (an injectable biologic that targets inflammation)
- What this could lead to
- If successful, this study could provide real-world evidence on how well secukinumab controls juvenile arthritis in children, potentially guiding better treatment decisions.
- What could go wrong
- As an observational study, it cannot prove cause and effect, and results may be influenced by other factors. The study is also limited to a specific age group and disease subtypes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Expected to start
-
Apr 2025
An estimate. Start dates often move.
- Expected to finish
-
Aug 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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