Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients (LUPUS)

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Lupus Erythematosus, Systemic

Treatments: Other: Ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02922114

CHRO-2013-02

Details and patient eligibility

About

Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Systemic Lupus Erythematosus patients (with or without joint involvement).
• subjects will have to sign the inform consent before the beginning of the study

Exclusion criteria

• Current pregnancy or no effective contraception

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

Ultrasonography

Experimental group

Description:

B-mode and power Doppler Ultrasonography examination

Treatment:

Other: Ultrasonography