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This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Other | This is an observational study, there is no treatment allocation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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.
| Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
jPsA per ILAR criteria
Arthritis and psoriasis, or
arthritis and at least 2 of the following:
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.
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| Up to 24 months |
| 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] | Up to 24 months |
| 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] | Up to 24 months |
| Time to treatment failure | Time to treatment failure defined as time from index date to loss of ACR Pedi 30, 50, and 70 response. | Up to 24 months |
| 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:
| Month 3 |
| 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:
| Up to 24 months |
| 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. | Up to 24 months |
| 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). | Up to 24 months |
| Number of participants by reasons of secukinumab discontinuation | Reasons for discontinuation:
| Up to 24 months |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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