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

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ClinicalTrials.gov Identifier: NCT02922114
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Other: Ultrasonography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients
Study Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasonography
B-mode and power Doppler Ultrasonography examination
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).




Primary Outcome Measures :
  1. Ultrasonography record (synovitis / tenosynovitis / effusion) [ Time Frame: Day 0 (there is only one point measurement in the study) ]
  2. Clinical joint assessment (synovitis / tenosynovitis / effusion) [ Time Frame: Day 0 ]
  3. Evaluate SELENA SLEDAI (C-SLEDAI) score [ Time Frame: Day 0 ]
  4. Evaluate musculoskeletal BILAG score [ Time Frame: Day 0 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922114


Locations
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France
Hopital Pellegrin
Bordeaux, France, 33076
Chu de Brest
Brest, France, 29609
CH du MANS
Le Mans, France, 72037
CHU Hôtel Dieu
Nantes, France, 44093
CHR d'Orléans
Orléans La Source, France, 45067
Hopital Pontchaillon - Chu de Rennes
Rennes, France, 35033
Chru de Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Carine SALLIOT CHR ORLEANS

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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT02922114     History of Changes
Other Study ID Numbers: CHRO-2013-02
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
Ultrasonography
Clinical assesment
joint abnormalities
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases