- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07634354
Sarcopenia and Juvenile Idiopathic Arthritis (SAJI)
Prevalence Study of Sarcopenia in Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis (JIA) is a rare chronic inflammatory rheumatic disease that begins during childhood and may persist into adulthood in many patients. In addition to joint pain, swelling, and long-term articular damage, chronic inflammatory diseases may also be associated with early sarcopenia, defined as a loss of muscle strength and muscle mass. While this association has been described in adult inflammatory rheumatic diseases, it has not been well studied in patients with JIA.
The aim of this study is to screen for sarcopenia in adolescents and adults with JIA in France. Sarcopenia will be assessed using validated questionnaires, hand grip strength measured with a Jamar dynamometer, and body composition measured by dual-energy X-ray absorptiometry (DEXA). Completion of validated questionnaires will assess nutritional status, fatigue, physical activity, and functional impact. Socio-demographic and clinical data will also be collected from medical records.
This multicenter cross-sectional study will be conducted between June 2026 and October 2027 in 11 French hospitals. Eligible participants are patients aged 15 to 40 years with JIA diagnosed according to ILAR criteria and followed in a French hospital.
This study will provide the first estimate of sarcopenia prevalence among patients with JIA in France. It will also help identify factors associated with sarcopenia and its impact on daily functioning and quality of life. In the longer term, the findings may help clinicians better identify patients at risk and support earlier management focused on disease control, physical activity, and nutritional care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a national multicenter cross-sectional study conducted in 11 French hospitals between June 2026 and October 2027. The study aims to assess sarcopenia in adolescents and adults with juvenile idiopathic arthritis (JIA) during a routine rheumatology follow-up visit.
After receiving study information and providing informed consent (with parental/legal guardian consent for minors, according to applicable regulations), participants will undergo a standardized single study assessment during routine care. This assessment will include measurement of hand grip strength using a Jamar dynamometer, whole-body dual-energy X-ray absorptiometry (DEXA) for body composition and appendicular lean mass evaluation, and completion of validated questionnaires addressing nutritional status, fatigue, physical activity, and functional impact. Additional socio-demographic and clinical data related to JIA history, disease characteristics, and treatments will be collected from medical records.
The study is designed to estimate the prevalence of sarcopenia in patients with JIA in France and to explore factors associated with sarcopenia and its functional impact. If sarcopenia is identified, additional management may be proposed by the treating physician as part of usual care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ambre HITTINGER-ROUX
- Phone Number: 0033 03 10 73 67 07
- Email: ahittinger-roux@chu-reims.fr
Study Contact Backup
- Name: Jean-Hugues SALMON
- Phone Number: 0033 03 26 78 44 21
- Email: jhsalmon@chu-reims.fr
Study Locations
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-
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Reims, France
- Marie Muller
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Contact:
- Ambre HITTINGER-ROUX
- Phone Number: 0033 03 10 73 67 07
- Email: ahittinger-roux@chu-reims.fr
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Contact:
- Jean-Hugues SALMON
- Phone Number: 0033 03 26 78 44 21
- Email: jhsalmon@chu-reims.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
inclusion criteria :
- Patients followed in French hospitals participating in the study for juvenile idiopathic arthritis, all forms combined, diagnosed according to the ILAR criteria defined in Edmonton in 2001
- Patients aged 15 to 40 years
- Affiliated to social security
- Agreeing to participate in the study and having given their written consent (signed consent form).
In the case of a minor patient, the consent of the patient and their legal guardians is required.
exclusion criteria :
- Patient under legal guardianship
- Patient not covered by social security
- Pregnant woman
- Inability to perform a functional test required by the study (grip test or whole-body DEXA scan)
- Inability to understand the questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients with juvenile idiopathic arthritis
Single group of adolescents and adults with juvenile idiopathic arthritis undergoing a standardized sarcopenia screening assessment at inclusion.
|
Participants will undergo a standardized single-visit assessment including hand grip strength measurement, whole-body DEXA scan for body composition, validated questionnaires, and collection of socio-demographic and clinical data from medical records.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sarcopenia
Time Frame: Day 1
|
A cross-sectional assessment of sarcopenia for each included patient will be performed at a participating hospital center: Performance of a hand grip test using a hand dynamometer (3 consecutive measurements on the dominant hand) and a whole-body DEXA scan with measurement of the appendiceal mass index Confirmation by the best grip test value < -2 SD according to the patient's age and sex on the reference curves associated with a pathological whole-body DEXA (appendiceal mass index ≤ 7 kg/m2 for men, ≤ 5.5 kg/m2 for women) |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue assessed by FACIT-F
Time Frame: Day 1
|
Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire
|
Day 1
|
|
Physical activity assessed by IPAQ
Time Frame: Day 1
|
Physical activity assessed using the International Physical Activity Questionnaire (IPAQ)
|
Day 1
|
|
Functional disability assessed by HAQ-DI
Time Frame: Day 1
|
Functional disability assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI).
|
Day 1
|
|
Health-related quality of life assessed by SF-12
Time Frame: Day 1
|
Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12).
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Arthritis, Juvenile
- Sarcopenia
Other Study ID Numbers
- PL26052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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