Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients
LUPUS
1 other identifier
interventional
152
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedOctober 4, 2016
September 1, 2016
1.5 years
September 27, 2016
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Ultrasonography record (synovitis / tenosynovitis / effusion)
Day 0 (there is only one point measurement in the study)
Clinical joint assessment (synovitis / tenosynovitis / effusion)
Day 0
Evaluate SELENA SLEDAI (C-SLEDAI) score
Day 0
Evaluate musculoskeletal BILAG score
Day 0
Study Arms (1)
Ultrasonography
EXPERIMENTALB-mode and power Doppler Ultrasonography examination
Interventions
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).
Eligibility Criteria
You may qualify if:
- Systemic Lupus Erythematosus patients (with or without joint involvement).
- subjects will have to sign the inform consent before the beginning of the study
You may not qualify if:
- Current pregnancy or no effective contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hopital Pellegrin
Bordeaux, 33076, France
Chu de Brest
Brest, 29609, France
CH du MANS
Le Mans, 72037, France
CHU Hôtel Dieu
Nantes, 44093, France
CHR d'Orléans
Orléans La Source, 45067, France
Hopital Pontchaillon - Chu de Rennes
Rennes, 35033, France
Chru de Tours
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carine SALLIOT
CHR ORLEANS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2016
First Posted
October 4, 2016
Study Start
September 1, 2013
Primary Completion
March 1, 2015
Study Completion
October 1, 2015
Last Updated
October 4, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share