Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007456
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-03-28
Brief Title:
Clinical Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Clinical Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis and Outcomes Evaluation During Transition to Adult Care
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None