Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients

Not Applicable

Completed

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Other: Ultrasonography

• Registration Number: NCT02922114
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-03
• Study Completion: 2015-10
• Status Verified: 2016-09
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-10-03
• Last Update Submitted: 2016-10-03
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

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Exclusion Criteria

• Current pregnancy or no effective contraception

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasonography	Ultrasonography	B-mode and power Doppler Ultrasonography examination

Primary Outcome Measures

Name	Time	Method
Clinical joint assessment (synovitis / tenosynovitis / effusion)	Day 0
Ultrasonography record (synovitis / tenosynovitis / effusion)	Day 0 (there is only one point measurement in the study)
Evaluate SELENA SLEDAI (C-SLEDAI) score	Day 0
Evaluate musculoskeletal BILAG score	Day 0

Trial Locations

Locations (7)

Hopital Pontchaillon - Chu de Rennes; 🇫🇷 Rennes, France

Hopital Pellegrin; 🇫🇷 Bordeaux, France

Chu de Brest; 🇫🇷 Brest, France

CHR d'Orléans; 🇫🇷 Orléans La Source, France

CH du MANS; 🇫🇷 Le Mans, France

Chru de Tours; 🇫🇷 Tours, France

CHU Hôtel Dieu; 🇫🇷 Nantes, France