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

Lupus Erythematosus, Systemic Clinical Trial

— LUPUS  

Official title:

Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922114
• Other study ID #: CHRO-2013-02
• Status: Completed
• Phase: N/A
• First received: September 27, 2016
• Last updated: October 3, 2016
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Other:
• Ultrasonography
B-mode and power Doppler ultrasonography examination.Ultrasonography assessments includes wrists, metacarpophalangeal, proximal interphalangeal, elbows, shoulders, knees, ankles, metatarsophalangeal and twenty six tendons (wrist extensors, finger flectors and tendons of the ankles).

Locations

Country	Name	City	State
France	Hopital Pellegrin	Bordeaux
France	Chu de Brest	Brest
France	CH du MANS	Le Mans
France	CHU Hôtel Dieu	Nantes
France	CHR d'Orléans	Orléans La Source
France	Hopital Pontchaillon - Chu de Rennes	Rennes
France	Chru de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonography record (synovitis / tenosynovitis / effusion)		Day 0 (there is only one point measurement in the study)	Yes
Primary	Clinical joint assessment (synovitis / tenosynovitis / effusion)		Day 0	Yes
Primary	Evaluate SELENA SLEDAI (C-SLEDAI) score		Day 0	Yes
Primary	Evaluate musculoskeletal BILAG score		Day 0	Yes