Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis

NCT ID: NCT06007456

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2026-03-15

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.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients at onset of juvenile arthritis

New diagnosis of JIA

No interventions assigned to this group

Patients with juvenile arthritis in follow up

Subjects with JIA already followed at Rheumatologic Service

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects under the age of 18 years
• Arthritis persisting for at least 6 weeks with no known cause

Exclusion Criteria

• 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Serena Pastore, MD

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

IRCCS Burlo Garofolo

Trieste, , Italy

Site Status: RECRUITING

(Department of Medical and Biological Sciences, Rheumatology Clinic, University of Udine

Udine, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Serena Pastore, MD

Role: CONTACT

serena.pastore@burlo.trieste.it

+390403785477

Facility Contacts

Serena Pastore, MD

Role: primary

serena.pastore@burlo.trieste.it

+390403785477

Alen Zabotti

Role: primary

alen.zabotti@asufc.sanita.fvg.it

Other Identifiers

RC 23/22

Identifier Type: -

Identifier Source: org_study_id