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

NCT06431750 | Withdrawn

• 1 other identifier: CAIN457FRU02
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile Idiopathic Arthritis; JIA; Secukinumab; Cosentyx

Outcome Measures

Primary Outcomes (3)

• Drug survival rate

  Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab

  24 months

• American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90 achievement rates

  The ACR Pedi 30/50/70/90 is defined as a minimum of 30/50/70/90 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30/50/70/90 percent. The ACR Pedi consists of 6 core criteria: 1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]); 4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (C-reactive protein \[CRP\]).

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

• Clinical remission/inactive disease rates by Wallace criteria

  To state the absence of disease activity (inactive phase of the disease), the patient must meet all of the listed criteria. * absence of joints with active arthritis, * absence of fever, rash, serositis, splenomegaly or generalized lymphadenopathy typical of juvenile arthritis; * absence of active uveitis, * normal ESR and (or) CRP, * absence of disease activity according to the doctor's general assessment (VAS), * morning stiffness less than 15 minutes.

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

Secondary Outcomes (9)

• Childhood Health Assessment Questionnaire (CHAQ) score

  Up to 24 months

• Physician global assessment of disease activity

  Up to 24 months

• Patient/legal representative global assessment of disease activity

  Up to 24 months

• Time to treatment failure

  Up to 24 months

• Proportion of patients not achieving ACR Pedi 30 response

  Month 3

Study Arms (1)

Secukinumab

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

Other: Secukinumab

Interventions

Secukinumab OTHER

This is an observational study, there is no treatment allocation.

Secukinumab

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
• Any medical or psychological condition in the investigator's opinion which may prevent the study participation.
• Concomitant conditions (Candida infections, other infections, inflammatory bowel disease \[IBD\], uveitis, skin and nail psoriasis for ERA patients, hepatitis B, hepatitis C, tuberculosis).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 29, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share