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OpenTrials
Completed

NCT Number: NCT04195789

Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Rhumatologie. Centre hospitalier Lyon Sud. 69310

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PO-PID

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2019
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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