Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound (PO-PID)

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Rheumatoid Arthritis; Lung Diseases, Interstitial
• Intervention / Treatment: Other: Lung sonography

• Study Type: Observational
• Enrollment (Estimated): 33

Contacts and Locations

• Study Contact: Name: Muriel PIPERNO, MD; Phone Number: +33 4 78 86 12 31; Email: muriel.piperno@chu-lyon.fr
• Study Contact Backup: Name: Cyrille CONFAVREUX, MD, PHD; Phone Number: +33 4 72 67 88 83; Email: cyrille.confavreux@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Service de Rhumatologie. Centre hospitalier Lyon Sud. 69310
    • Contact: Muriel PIPERNO, MD; Phone Number: +33 4 78 86 12 31; Email: muriel.piperno@chu-lyon.fr
    • Contact: Cyrille CONFAVREUX, MD,PHD; Phone Number: +33 4 72 67 88 83; Email: cyrille.confavreux@chu-lyon.fr
    • Principal Investigator: Muriel PIPERNO, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients followed for a rheumatoid arthritis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sample population; Patients with Rheumatoid Arthritis consultant for the start of a biotherapy or targeted therapy agreeing to participate.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Estimated): May 4, 2024
• Study Completion (Estimated): May 4, 2026

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 69HCL19_0859

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No