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NCT Number: NCT07634354

Sarcopenia and 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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Atrophy Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sarcopenia Signs and Symptoms Skin and Connective Tissue Diseases

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sarcopenia screening assessment

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Fatigue assessed by FACIT-F

    Time frame: Day 1

    Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire

  2. Physical activity assessed by IPAQ

    Time frame: Day 1

    Physical activity assessed using the International Physical Activity Questionnaire (IPAQ)

  3. Functional disability assessed by HAQ-DI

    Time frame: Day 1

    Functional disability assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ambre HITTINGER-ROUX

CONTACT

[email protected]

03 10 73 67 07 ext. 0033

Jean-Hugues SALMON

CONTACT

[email protected]

03 26 78 44 21 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Prevalence Study of Sarcopenia in Juvenile Idiopathic Arthritis

Acronym: SAJI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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