Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound

NCT04195789 | Completed

• 1 other identifier: 69HCL19_0859
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Lung Diseases, Interstitial; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Sample population

Patients with Rheumatoid Arthritis consultant for the start of a biotherapy or targeted therapy agreeing to participate.

Other: Lung sonography

Interventions

Lung sonography OTHER

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.

Sample population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed for a rheumatoid arthritis

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Rhumatologie. Centre hospitalier Lyon Sud. 69310

Pierre-Bénite, 69310, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* In routine care a blood test (blood count, platelets, ionogram, VS (velocity sedimentation), CRP (C reactive protein), liver test, BNP (B-type natriuretic peptide), electrophoresis of serum proteins, quantiferon, HIV serologies, HBV : hepatitis B virus , HCV: hepatitis C virus) will be performed on the day of inclusion visit (V0). * Two more tubes of 4cc will be collected for a serum bank.

MeSH Terms

Conditions

Lung Diseases; Lung Diseases, Interstitial; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: August 4, 2020
• Primary Completion: May 4, 2024
• Study Completion: June 4, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

FR (1)