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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02922114

Acronym

LUPUS

Enrollment

152

Registered

2016-10-04

Start date

2013-09-30

Completion date

2015-10-31

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Systemic

Keywords

Ultrasonography, Clinical assesment, joint abnormalities

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.

Interventions

OTHERUltrasonography

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026