Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound

Completed

• Conditions: Lung Diseases, Interstitial; Lung Diseases; Rheumatoid Arthritis
• Interventions: Other: Lung sonography

• Registration Number: NCT04195789
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating.

Ultrasound could be used to detect these disorders with a very good sensitivity and specificity. This exam offers the advantage of being non radiating, inexpensive, and accessible to the rheumatologist who already uses it in their daily practice.

The investigators want to assess the lung ultrasound performance compared with the gold standard.

Patients will be included during a regular follow-up consultation with their referent rheumatologist. If there is an indication of first line biotherapy or targeted therapy the doctor will propose to the patient to participate in the study, give him the information leaflet, collect orally non-opposition, and will complete a survey for evaluation of the general health and potential risk factors for interstitial lung.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Study Start: 2020-08-04
• Primary Completion: 2024-05-04
• Study Completion: 2024-06-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Men and women over the age of 18
• With rheumatoid arthritis meeting the criteria ACR (American College of Rheumatology)/ EULAR (EUropean League Against Rheumatism) 2010
• Never received any biotherapy or targeted therapy
• Having an indication of introduction of biotherapy or therapy targeted (JAK inhibitors) (JAK : Janus kinase)

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Exclusion Criteria

• Refusal to participate in the study
• Known pulmonary disease that can alter lung interstitium: cardiac decompensation, COPD (chronic obstructive pulmonary disease), thoracic surgery, infection pulmonary
• Patient with respiratory functional signs suggestive of PID (Diffuse interstitial lung disease)
• Patient with signs of cardiac decompensation
• Patient with pulmonary auscultation suggestive of PID
• Pregnant or lactating woman
• Psychiatric pathology seriously hindering understanding
• Difficulty understanding oral French
• Person deprived of liberty or under legal protection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sample population	Lung sonography	Patients with Rheumatoid Arthritis consultant for the start of a biotherapy or targeted therapy agreeing to participate.

Primary Outcome Measures

Name	Time	Method
Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.	Month 12	To estimate the sensitivity and specificity of pulmonary ultrasound compared to CT scans in patients with rheumatoid arthritis consulting at the Lyon South Hospital Centre or the Edouard Herriot Hospital for the start-up of biotherapy or targeted therapy. (CT : computerized tomography)

Trial Locations

Locations (1)

Service de Rhumatologie. Centre hospitalier Lyon Sud. 69310; 🇫🇷 Pierre-Bénite, France