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

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasonography
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lupus Erythematosus, Systemic focused on measuring Ultrasonography, Clinical assesment, joint abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Pellegrin
  • Chu de Brest
  • CH du MANS
  • CHU Hôtel Dieu
  • CHR d'Orléans
  • Hopital Pontchaillon - Chu de Rennes
  • Chru de Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasonography

Arm Description

B-mode and power Doppler Ultrasonography examination

Outcomes

Primary Outcome Measures

Ultrasonography record (synovitis / tenosynovitis / effusion)
Clinical joint assessment (synovitis / tenosynovitis / effusion)
Evaluate SELENA SLEDAI (C-SLEDAI) score
Evaluate musculoskeletal BILAG score

Secondary Outcome Measures

Full Information

First Posted
September 27, 2016
Last Updated
October 3, 2016
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT02922114
Brief Title
Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients
Acronym
LUPUS
Official Title
Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Ultrasonography, Clinical assesment, joint abnormalities

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonography
Arm Type
Experimental
Arm Description
B-mode and power Doppler Ultrasonography examination
Intervention Type
Other
Intervention Name(s)
Ultrasonography
Intervention Description
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).
Primary Outcome Measure Information:
Title
Ultrasonography record (synovitis / tenosynovitis / effusion)
Time Frame
Day 0 (there is only one point measurement in the study)
Title
Clinical joint assessment (synovitis / tenosynovitis / effusion)
Time Frame
Day 0
Title
Evaluate SELENA SLEDAI (C-SLEDAI) score
Time Frame
Day 0
Title
Evaluate musculoskeletal BILAG score
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine SALLIOT
Organizational Affiliation
CHR ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Chu de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CH du MANS
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
CHU Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHR d'Orléans
City
Orléans La Source
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Pontchaillon - Chu de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Chru de Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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