[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549264":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":10,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":10},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Secukinumab",null,"pediatric patients with active ERA\u002FjPsA for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 8 weeks prior to enrollment",[13],"Other: Secukinumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"OTHER","This is an observational study, there is no treatment allocation.",[9],[20],{"name":21,"affiliation":21,"role":22},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[24,28],{"name":21,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":21,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100549264","prospective-observational-study-to-evaluate-secukinumab-treatment-effectiveness-in-pediatric-patients-with-active-juvenile-enthesitis-related-or-psoriatic-arthritis-100549264",false,"NCT06431750","Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis","Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)","Toddler","Inclusion Criteria:\n\n1. Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.\n2. Age ≥6 to \\\u003C18 years old.\n3. Recognized physician diagnosis of active ERA or jPsA:\n\n   * ERA per ILAR criteria:\n\n     * Peripheral arthritis and enthesitis, or\n     * Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or\n     * 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.\n   * jPsA per ILAR criteria\n\n     * Arthritis and psoriasis, or\n     * arthritis and at least 2 of the following:\n\n       * Dactylitis\n       * Nail pitting or onycholysis\n       * Psoriasis in a first-degree relative.\n4. Patient was prescribed with secukinumab within 4-8 weeks before inclusion.\n5. 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.\n6. The Purified Protein Derivative (PPD) Skin Test for Tuberculosis and\u002For Negative T-SPOT test and\u002For TB-feron test before secukinumab treatment and every 6 months.\n\nExclusion Criteria:\n\n1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).\n2. Chronic recurrent infections.\n3. Clinically significant infection exacerbation, including active tuberculosis.\n4. Age \\\u003C6 years or ≥18 years.\n5. Pregnancy and breastfeeding.\n6. Patients participating in parallel in an interventional clinical trial.\n7. Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.\n8. Patients within the safety follow-up phase of interventional study.\n9. Active inflammatory bowel disease at inclusion.\n10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.\n11. Any medical or psychological condition in the investigator's opinion which may prevent the study participation.\n12. Concomitant conditions (Candida infections, other infections, inflammatory bowel disease \\[IBD\\], uveitis, skin and nail psoriasis for ERA patients, hepatitis B, hepatitis C, tuberculosis).","ALL","6 Years","18 Years",{"count":43,"type":44},150,"ESTIMATED","OBSERVATIONAL","This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis",[48],"Juvenile Idiopathic Arthritis",[48,50,9,51],"JIA","Cosentyx","NOT_YET_RECRUITING","2025-01-12",{"date":55,"type":56},"2025-01-14","ACTUAL",{"date":58,"type":44},"2025-04-30",{"date":60,"type":44},"2028-08-30",{"name":21,"class":6}]