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

NCT ID: NCT02922114

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Lupus Erythematosus, Systemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasonography

B-mode and power Doppler Ultrasonography examination

Group Type EXPERIMENTAL

Ultrasonography

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carine SALLIOT

Role: PRINCIPAL_INVESTIGATOR

CHR ORLEANS

Locations

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Hopital Pellegrin

Bordeaux, , France

Site Status

Chu de Brest

Brest, , France

Site Status

CH du MANS

Le Mans, , France

Site Status

CHU Hôtel Dieu

Nantes, , France

Site Status

CHR d'Orléans

Orléans La Source, , France

Site Status

Hopital Pontchaillon - Chu de Rennes

Rennes, , France

Site Status

Chru de Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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CHRO-2013-02

Identifier Type: -

Identifier Source: org_study_id

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