Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis
- Conditions
- Juvenile Idiopathic Arthritis
- Registration Number
- NCT06007456
- Lead Sponsor
- IRCCS Burlo Garofolo
- Brief Summary
Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in children, is defined as arthritis persisting for at least 6 weeks with no known cause in a patient under the age of 16. The term JIA is an umbrella that includes very different diseases. The current International League of Associations for Rheumatology (ILAR) classification divides JIA patients into 7 categories based on number of involved joints and time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis. This classification groups together patients with different disease and divides patients with the same disease. In the first case, unifying distinct diseases could lead to undifferentiated therapeutic choices, moving away from the modern concept of therapeutic personalization. In the second case, similarities between paediatric and adult arthritis could not be found. This involves both a loss of collaboration with the adult rheumatologist and the difficulty in accessing possibly effective therapies approved only for adult arthritis.
In clinical practice, it is increasingly evident that the number of affected joints and the speed of joint involvement are not useful criteria for defining the type and severity of disease. Joint counts lead to underestimate the importance of joint distribution in the identification of distinct forms of arthritis. A recent study found that patterns of joint involvement represent prognostic features, so grouping patients by joint pattern and degree of localization may help clinicians tailor treatments based on predicted disease trajectories. Another important point to differentiate some forms of arthritis is the presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS) has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in patients with JIA. Recent studies underline the important role of MSUS findings to assess disease activity and assist disease classification. In recent years, the need has emerged to replace the ILAR criteria with a new nomenclature based on the disease biology. This approach could help clinicians to choose a personalized therapeutic strategy for patients with arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Subjects under the age of 18 years
- Arthritis persisting for at least 6 weeks with no known cause
- No consent from the patients' guardians
- Patients with Systemic onset Juvenile Idiopathic Arthritis
- Patients who developed arthritis on a pre-existing inflammatory disorder such as Inflammatory Bowel Disease, and had received previous treatments
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess joint damage by radiological examination during the transition to adult care Between 14-17 years of age Radiographs will be performed to assess the presence of joint damage
To evaluate disease activity by the Juvenile Arthritis Disease score during the transition to adult care Between 14-17 years of age The Juvenile Arthritis Disease score (JADAS) includes 4 measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) (0=no activity-10=maximum activity); parent global assessment of well-being, measured on a 0-10 VAS (0=very well-10=very poor); the erythrocyte sedimentation rate, normalized to a 0 to 10 scale; and a count of joints with active disease. The final score is calculated as the sum of the scores of these four components (higher scores indicate higher disease activity).
To evaluate disease activity by the Health Assessment Questionnaire - Disability Index during the transition to adult care Between 14-17 years of age The Health Assessment Questionnaire - Disability Index (HAQ-DI) includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.
- Secondary Outcome Measures
Name Time Method To evaluate non-inflammatory pain by the widespread pain index scale during transition to adult care Between 14-17 years of age Pain will be evaluated through the widespread pain index (WPI) scale that assesses the presence of pain in 19 designated body locations over the past 7 days. Each location is equal to a score of 1. The WPI indicates the total number of areas that are painful, giving a maximum value of 19. WPI score can range from 0 to 19.
Trial Locations
- Locations (2)
IRCCS Burlo Garofolo
🇮🇹Trieste, Italy
(Department of Medical and Biological Sciences, Rheumatology Clinic, University of Udine
🇮🇹Udine, Italy