Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 主要终点
- Clinical remission/inactive disease rates by Wallace criteria
研究概览
简要总结
This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
- •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).
研究组 & 干预措施
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
干预措施: Secukinumab (Other)
结局指标
主要结局
Clinical remission/inactive disease rates by Wallace criteria
时间窗: Month 3, Month 6, Month 12, Month 18, and Month 24
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.
American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90 achievement rates
时间窗: Month 3, Month 6, Month 12, Month 18, and Month 24
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 \[CRP\]).
Drug survival rate
时间窗: 24 months
Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab
次要结局
- Time to treatment failure(Up to 24 months)
- Proportion of patients not achieving ACR Pedi 30 response(Month 3)
- Juvenile Spondyloarthritis (JSpA) Disease Activity - JSpADA(Up to 24 months)
- Patient/legal representative global assessment of disease activity(Up to 24 months)
- Number of participants by reasons of secukinumab discontinuation(Up to 24 months)
- Psoriasis Area and Severity Index (PASI) for patients with Juvenile Psoriatic Arthritis (jPsA)(Up to 24 months)
- Childhood Health Assessment Questionnaire (CHAQ) score(Up to 24 months)
- Physician global assessment of disease activity(Up to 24 months)
- Disease activity index in 71 joints Juvenile Arthritis Disease Activity Score (JADAS71)(Up to 24 months)