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Juvenile Idiopathic ArthritisToddlerNCT06431750

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

An observational study of Juvenile Idiopathic Arthritis, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Secukinumab
How many people
0 participants
Where
No sites listed yet
Study dates
30 Apr 2025to 30 Aug 2028
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Active inflammatory bowel disease at inclusion.
  • 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).

About this study

Official title: Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)

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

Read the detailed description

Rheumatologists and pediatricians actively managing pediatric Enthesitis-related Arthritis (ERA) and Juvenile Psoriatic Arthritis (jPsA) in different regions of Russia are planned to participate in the study. To be include in this study, physicians must consult more than 10 pediatric patients with ERA/jPsA in a typical month. Any pediatric patients with active ERA/jPsA who started secukinumab treatment (index date) within 4-8 weeks prior to inclusion can be enrolled. At the inclusion retrospective data collection is planned, then data will be collected 3 months of treatment), 6, 12, 18, and 24 months after index date. Therefore, maximum duration of prospective observation is expected to be 23 months. Data collection schedule fits routine (Juvenile Idiopathic Arthritis) JIA management guidelines for patients receiving biologics stating that treatment effectiveness should be evaluated at 3 and 6 months after biologic initiation and every 6 months thereafter. At each visit effectiveness and tolerability parameters, as well as the patients' Quality of life (QoL) will be documented. Retrospective data will be collected for medical history and JIA treatment, including secukinumab before inclusion, as well to describe all necessary parameters since the Index date. Expected look-back period is 12 months.

Initiation of secukinumab treatment will be considered the index date.

Being tested
Secukinumab
Keywords
Juvenile Idiopathic Arthritis, JIA, Secukinumab, Cosentyx
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabOther

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

Study groups in NCT06431750
Study groupRoleWhat they receive
Secukinumabpediatric 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
Receives: Other: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug survival rate

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

    Measured: 24 months

  2. 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]).

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

  3. 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.

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

Secondary outcomes (9)

  1. Childhood Health Assessment Questionnaire (CHAQ) score

    Describes the child's usual activities in eight domains over the past week. It include dressing, getting up, eating, walking, hygiene, reaching overhead objects, grip and activities. Each question is scored from 0 to 3 (0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do). The score for each of the eight functional areas will be averaged to calculate the disability index.

    Measured: Up to 24 months

  2. Physician global assessment of disease activity

    Physician global assessment of disease activity assessed on a VAS scale of 0 [no activity] to 10 [extreme activity]

    Measured: Up to 24 months

  3. Patient/legal representative global assessment of disease activity

    Patient/legal representative global assessment of disease activity assessed on a VAS scale of 0 [no activity] to 10 [extreme activity]

    Measured: Up to 24 months

  4. Time to treatment failure

    Time to treatment failure defined as time from index date to loss of ACR Pedi 30, 50, and 70 response.

    Measured: Up to 24 months

  5. Proportion of patients not achieving ACR Pedi 30 response

    The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >30 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]).

    Measured: Month 3

  6. Disease activity index in 71 joints Juvenile Arthritis Disease Activity Score (JADAS71)

    Score to evaluate the number of joints inflamed. A joint is considered to be inflamed when at leats two of the following criteria are present:

    • pain
    • Swelling
    • limited motion. The score range (total) is from 0-101, where higher scores indicate worse outcome.

    Measured: Up to 24 months

  7. Juvenile Spondyloarthritis (JSpA) Disease Activity - JSpADA

    The JSpADA score is a comprehensive

    clinical assessment tool designed to measure the impact of juvenile spondyloarthritis on the patient. The JSpADA scale includes 8 indicators that assess the signs and symptoms of spondyloarthritis. Patients receive an overall score based on scores on each of 8 indicators. There are two options for assessing morning stiffness, clinical sacroiliitis, uveitis and back mobility: presence or absence. Number of joints with active arthritis: 0 joints = 0; 1-2 joints = 0.5; > 2 joints = 1; Number of active enthesites: 0 = 0; 1-2 = 0.5; > 2 = 1; Patient-Reported Pain Score (VAS 0-10): 0 = 0; 1-4 = 0.5; 5-10 = 1; Assessment of ESR or CRP level: normal = 0; 1-2x = 0.5; > 2x = 1.

    As a result, we add up the scores for the obtained indicators and get an overall score, and the higher it is, the higher the disease activity.

    Measured: Up to 24 months

  8. Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA)

    Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA) to be provided. Score can range from 0 (no disease) to 72 (maximal disease).

    Measured: Up to 24 months

  9. Number of participants by reasons of secukinumab discontinuation

    Reasons for discontinuation:

    • lack of efficacy,
    • adverse events
    • administrative reasons (no medication available in the hospital, etc.)
    • lack of patient's adherence
    • patient's or legal representative's wish
    • other.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start30 Apr 2025 (estimated)
  3. Primary completion30 Aug 2028 (estimated)
  4. Study completion30 Aug 2028 (estimated)

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431750
Sponsor's protocol ID
CAIN457FRU02
Acronym
Toddler
Status last verified
Aug 2026
First submitted
30 Apr 2024
Last updated
7 Aug 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Juvenile Idiopathic Arthritis, run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug survival rate (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06431750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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