An interventional study of Conventional PFT; IOS; CANO; Chest HRCT in Rhumatoid Arthisis and Systemic Sclerosis (SSc), sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
The purpose of this prospective real-world study is to assess the presence and severity of small airway dysfunction in patients with rheumatoid arthritis or systemic sclerosis and to examine the relationships between the various markers of small airway dysfunction and disease activity.
Interstitial lung disease (ILD) is a serious pulmonary complication of rheumatoid arthritis (RA) and systemic sclerosis (SSc) and is associated with substantial morbidity and mortality. Patients with symptomatic ILD have been reported to have a two-fold to tenfold higher risk of death than those without ILD. Early identification of patients with RA or SSc who are at risk of developing progressive ILD therefore remains a major clinical challenge.
Current international recommendations advocate regular pulmonary function testing (PFT), including forced spirometry and measurement of the diffusing capacity of the lung for carbon monoxide (DLCO), as well as the six-minute walk test, with chest computed tomography (CT) performed when clinically indicated, for the detection and monitoring of ILD in patients with RA or SSc. However, these conventional investigations may have limited sensitivity for detecting early pulmonary abnormalities, and PFT results may remain within the normal range during the initial stages of ILD. Recent studies have shown that small airway dysfunction (SAD) may occur early in the course of pulmonary involvement in patients with RA or SSc, even in the absence of radiological evidence of established pulmonary fibrosis.
The present descriptive study therefore aimed to characterize pulmonary abnormalities in patients with RA or SSc using a multimodal approach that combine assessment of ventilatory mechanics by impulse oscillometry (IOS), evaluation of distal airway inflammation through multiple-flow exhaled nitric oxide measurements (CANO), and high-resolution computed tomography (HRCT) of the chest.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 184 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion Criteria:
Patients unable to perform any of the following pulmonary function tests (PFTs):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional PFT; IOS; CANO; Chest HRCT
Diagnostic Test: Conventional PFT; IOS; CANO; Chest HRCT
Conventional PFT; IOS; CANO; Chest HRCT
Diagnostic Test: Conventional PFT; IOS; CANO; Chest HRCT
Conventional PFT; IOS; CANO; Chest HRCT
Respiratory impedance
Measurement of respiratory impedance - Impulse Oscillometry (IOS)
Time frame: Day of inclusion
Alveolar concentration of exhaled nitric oxide
Measurement of the alveolar concentration of exhaled nitric oxide (CANO)
Time frame: Day of inclusion
Pulmonary double diffusion
Measurement of pulmonary double diffusion (Diffusing capacity for carbon monoxide (DLCO), Diffusing capacity of the lung for nitric oxide (DLNO))
Time frame: Day of inclusion
Lung volumes measurement
Plethysmography
Time frame: Day of inclusion
Chest HRCT
High-resolution computed tomography of the chest using paired inspiratory and expiratory scans for visualizing air trapping and diagnosing small airway disease
Time frame: Day of inclusion
Flow-volume curve
Spirometry
Time frame: Day of inclusion
Disease Activity Score 28 (DAS-28-CRP)
Groupe "Rheumatoid arthritis" : Rheumatoid arthritis activity measurement
Time frame: Day of inclusion
Modified Rodnan Skin Score (mRSS)
Groupe "systemic scleroderma" : systemic scleroderma activity measurement
Time frame: Day of inclusion
Antibody levels
Measurement of antibody levels
Time frame: Day of inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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