Rhumatoid ArthisisVAD-PR_ScSNCT07924124
Small Airway Dysfunction in Rheumatoid Arthritis and Systemic Sclerosis
A study testing Conventional PFT; IOS; CANO; Chest HRCT in people with Rhumatoid Arthisis and Systemic Sclerosis (SSc), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhumatoid Arthisis, Systemic Sclerosis (SSc)
- What is being tested?
- Conventional PFT; IOS; CANO; Chest HRCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Diagnosis of rheumatoid arthritis (RA) or systemic sclerosis (SSc) confirmed by a rheumatologist
- Patients affiliated with or covered by a social security scheme
- Patients who have received information regarding the research and have signed the consent form.
Who cannot join
- Presence of interstitial lung disease (ILD) identified prior to recruitment
- History of treatment with medications known to induce pulmonary fibrosis (bleomycin, amiodarone) or prior radiation therapy for the local treatment of thoracic malignancies (breast cancer, lung cancer)
- Patients unable to perform any of the following pulmonary function tests (PFTs):
- Impulse oscillometry (IOS)
- Forced spirometry
- Measurement of lung volumes via plethysmography
- Individuals covered under Articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under legal guardianship or curatorship, individuals deprived of their liberty, pregnant or breastfeeding women)
- Patients who do not understand the French language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Rheumatology Department - Cochin hospital
Paris, IDF, 75014
Stéphane HILLIQUIN, MD, 0033158414141, stephane.hilliquin@aphp.fr
Stéphane HILLIQUIN
About this study
Official title: Study on Small Airway Dysfunction in Rheumatoid Arthritis and Systemic Sclerosis
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.
Read the detailed description
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.
- Conditions
- Rhumatoid Arthisis, Systemic Sclerosis (SSc)
- Being tested
- Conventional PFT; IOS; CANO; Chest HRCT
- Keywords
- Small airway dysfunction, Pulmonary function test, Impulse oscillometry, Alveolar inflammation, Chest HRCT
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PFT; IOS; CANO; Chest HRCTDiagnostic test
Conventional PFT; IOS; CANO; Chest HRCT
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | Experimental | Conventional PFT; IOS; CANO; Chest HRCT Receives: Diagnostic Test: Conventional PFT; IOS; CANO; Chest HRCT |
| Systemic sclerosis | Experimental | Conventional PFT; IOS; CANO; Chest HRCT Receives: Diagnostic Test: Conventional PFT; IOS; CANO; Chest HRCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory impedance
Measurement of respiratory impedance - Impulse Oscillometry (IOS)
Measured: Day of inclusion
Alveolar concentration of exhaled nitric oxide
Measurement of the alveolar concentration of exhaled nitric oxide (CANO)
Measured: 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))
Measured: Day of inclusion
Secondary outcomes (6)
Lung volumes measurement
Plethysmography
Measured: 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
Measured: Day of inclusion
Flow-volume curve
Spirometry
Measured: Day of inclusion
Disease Activity Score 28 (DAS-28-CRP)
Groupe "Rheumatoid arthritis" : Rheumatoid arthritis activity measurement
Measured: Day of inclusion
Modified Rodnan Skin Score (mRSS)
Groupe "systemic scleroderma" : systemic scleroderma activity measurement
Measured: Day of inclusion
Antibody levels
Measurement of antibody levels
Measured: Day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhumatoid ArthisisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Anh Tuan Dinh-Xuan, MD, PhD, Study director, Physiology Department - Cochin hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924124
- Sponsor's protocol ID
- APHP260889
- Other IDs
- 2026-A01513-48
- Acronym
- VAD-PR_ScS
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Small Airway Dysfunction in Rheumatoid Arthritis and Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07924124
- Acronym / sponsor ID
- VAD-PR_ScS / APHP260889
- Conditions
- Rhumatoid Arthisis, Systemic Sclerosis (SSc)
- Keywords
- Small airway dysfunction, Pulmonary function test, Impulse oscillometry, Alveolar inflammation, Chest HRCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | Experimental | Diagnostic Test: Conventional PFT; IOS; CANO; Chest HRCTConventional PFT; IOS; CANO; Chest HRCT |
| Systemic sclerosis | Experimental | Diagnostic Test: Conventional PFT; IOS; CANO; Chest HRCTConventional PFT; IOS; CANO; Chest HRCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age
- Diagnosis of rheumatoid arthritis (RA) or systemic sclerosis (SSc) confirmed by a rheumatologist
- Patients affiliated with or covered by a social security scheme
- Patients who have received information regarding the research and have signed the consent form.
Key exclusion criteria (8 listed)
- Presence of interstitial lung disease (ILD) identified prior to recruitment
- History of treatment with medications known to induce pulmonary fibrosis (bleomycin, amiodarone) or prior radiation therapy for the local treatment of thoracic malignancies (breast cancer, lung cancer)
- Patients unable to perform any of the following pulmonary function tests (PFTs):
- Individuals covered under Articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under legal guardianship or curatorship, individuals deprived of their liberty, pregnant or breastfeeding women)
- Patients who do not understand the French language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PFT; IOS; CANO; Chest HRCTConventional PFT; IOS; CANO; Chest HRCT | Diagnostic test | Rheumatoid arthritis, Systemic sclerosis |
Primary outcome
Respiratory impedance
Time frame: Day of inclusion
Measurement of respiratory impedance - Impulse Oscillometry (IOS)
Alveolar concentration of exhaled nitric oxide
Time frame: Day of inclusion
Measurement of the alveolar concentration of exhaled nitric oxide (CANO)
Pulmonary double diffusion
Time frame: Day of inclusion
Measurement of pulmonary double diffusion (Diffusing capacity for carbon monoxide (DLCO), Diffusing capacity of the lung for nitric oxide (DLNO))
6 secondary outcomes
Lung volumes measurement
Time frame: Day of inclusion
Chest HRCT
Time frame: Day of inclusion
Flow-volume curve
Time frame: Day of inclusion
Disease Activity Score 28 (DAS-28-CRP)
Time frame: Day of inclusion
Modified Rodnan Skin Score (mRSS)
Time frame: Day of inclusion
Antibody levels
Time frame: Day of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anh Tuan Dinh-Xuan, MD, PhD study director
Physiology Department - Cochin hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional PFT; IOS; CANO; Chest HRCT in people with Rhumatoid Arthisis and Systemic Sclerosis (SSc), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anh Tuan Dinh-Xuan, MD, PhD (0033158412336, anh-tuan.dinh-xuan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory impedance (time frame: Day of inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.