Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound

Rheumatoid Arthritis Clinical Trial

— PO-PID  

Official title:

Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195789
• Other study ID #: 69HCL19_0859
• Status: Recruiting
• Start date: August 4, 2020
• Est. completion date: May 4, 2026

Study information

• Verified date: November 2023
• Source: Hospices Civils de Lyon
• Contact: Muriel PIPERNO, MD
• Phone: 4 78 86 12 31
• Email: muriel.piperno[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: May 4, 2026
• Est. primary completion date: May 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lung Diseases
• Lung Diseases, Interstitial
• Rheumatoid Arthritis

Intervention

Other:
• Lung sonography
Realization of a lung sonography with scoring of the number of B-lines exploring 14 intercostal spaces. Duration of the exam : twenty minutes. Recording for a second analysis by another lung specialist.

Locations

Country	Name	City	State
France	Service de Rhumatologie. Centre hospitalier Lyon Sud. 69310	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.	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)	Month 12