Evaluation of Articular Damage in Patients With Juvenile Idiopathic Arthritis (JIA) After Transition to Adult Care and Correlation With Disease Characteristics and Treatments.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Mean difference between groups in the radiographic Sharp/Van der Heijde score
研究概览
简要总结
Juvenile idiopathic arthritis (JIA) is the most common childhood chronic rheumatic disease, encompassing all forms of arthritis that persist for more than 6 weeks, with onset before age 16, after exclusion of other causes of arthritis. It is a heterogeneous disease, whose complexity is only partially encompassed by the actual classification criteria and it is characterized by prolonged synovial inflammation that can lead to joint destruction.
Whilst the assessment of structural joint damage is part of the routinary evaluation of disease severity and progression in patients with rheumatoid arthritis (RA), to the extent that it is considered a key end-point outcome in treatment efficacy studies, this is not the same for JIA. Some recommendations have been elaborated based on expert opinion, but only recently they have been translated into clinical practice. Such a discrepancy in approaching chronic arthritis has been for many years due to the lack of articular damage radiographic scoring system validated for pediatric age. Actually, joint space narrowing, bone erosions and demineralization, which is typical of adult articular damage, are not the same changes observed in pediatric population where early growth plate closure, epiphyseal deformity and growth asymmetries can be the major signs.
The transition process from the pediatric to the adult health care team is a critical moment in the clinical history of patients with JIA, often hampered by the absence of specific criteria for the assessment of disease activity, the lack of specific treatment recommendations for JIA adult patients, the poor adolescent-specific training for adult rheumatologists, and the lack of communication between pediatric and adult centers. Adult patients with JIA have their own specific identity and should not be inappropriately re-categorized as having RA, ankylosing spondylitis or another condition once transitioned to the adult rheumatologist.
The aim of this study is to quantify the articular damage of adult patient with JIA after closure of growth plates. This represent a sort of starting burden carried by the patients who receive transition to the adult rheumatologist care and which should be minimized in order to reduce long-term complications. Furthermore, the study aims to analyze possible correlations between the presence of articular damage, therapies taken in pediatric age, and characteristics of JIA at the onset and during the clinical course of the disease
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 16 to 25 years who received a diagnosis of JIA in pediatric age according to International League of Associations for Rheumatology criteria (2001) and who have begun the process of transition to adult care.
- •Young adults undergoing healthcare transition process from the the pediatric to adult rheumatology since
- •Patients with radiological evidence of joint plates closure.
- •X-ray images of hands, hips, and knees available
排除标准
- •Patients cared at the adult rheumatology clinic who received a diagnosis of arthritis in the adult age.
- •Patients with other orthopedic conditions or affected by other diseases leading to osteoporosis or skeletal deformities.
- •Patients affected by other rheumatological conditions who underwent healthcare transition process from the the pediatric to adult rheumatology center.
研究组 & 干预措施
Methotrexate group
Patients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on methotrexate therapy
干预措施: Methotrexate (Drug)
Biologic therapy group
Patients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on biologic therapy
干预措施: Biological Drug (Drug)
结局指标
主要结局
Mean difference between groups in the radiographic Sharp/Van der Heijde score
时间窗: At transition from pediatric to adult care, on average at the age of 18
Radiological examinations of small joints (hands/wrists) will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Sharp/Van der Heijde score, evaluating joint space narrowing and erosion with a range from 0 to 4 and from 0 to 5, respectively. The total Sharp/van der Heijde score is calculated as the sum of the scores for joint space narrowing (range 0-120) and erosion (range 0-160) and ranges from 0 to 280.
Mean difference between groups in the radiographic Larsen score
时间窗: At transition from pediatric to adult care, on average at the age of 18
Radiological examinations of knees and hips will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Larsen score. The grading scale ranges from 0 to 5 (0=intact bony outlines and normal joint space, 5=mutilating changes). The Larsen score ranges from 0 to 120.
次要结局
- Associations between the radiographic Sharp/Van der Heijde score and clinical characteristics(At transition from pediatric to adult care, on average at the age of 18)
- Associations between the radiographic Larsen score and clinical characteristics(At transition from pediatric to adult care, on average at the age of 18)