Rheumatoid Arthritis-Associated Interstitial Lung DiseaseRAIDNCT06184893
Rheumatoid Arthritis-associated Interstitial Lung Disease Definition
An observational study of Rheumatoid Arthritis-Associated Interstitial Lung Disease, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
This is a prospective multicenter study in southern Belgium to determine the prevalence and incidence of interstitial lung disease in patients with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis-Associated Interstitial Lung Disease
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Nov 2023to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients with rheumatoid arthritis visiting their rheumatologist in South of Belgium and willing to participate
Who may be able to join
- Diagnosis of rheumatoid arthritis according to the criteria of the American Society of Rheumatology
- Age > 18 years
- Willing to participate in the study and sign the informed consent form (ICF) of participants or their legal authorized representative
- RAIDbio subcohort : available data for one of the following analysis of biomarkers: volatile organic compounds, induced sputum or blood markers
- RAIDomix : available data for high resolution computed tomography of the chest
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Liege
Liège, 4000
Julien Guiot, 00324/3237881, j.guiot@chuliege.be
Anna Denis, 00324/3237881, anna.denis@chuliege.be
About this study
Official title: Multi-centric Prospective and Observational Study of Prevalence and Incidence of Interstitial Lung Diseases in Patients With Rheumatoid Arthritis
This is a prospective multicenter study in southern Belgium to determine the prevalence and incidence of interstitial lung disease in patients with rheumatoid arthritis (RA).
Read the detailed description
This is a prospective multi-centric longitudinal study of the prevalence and incidence of pulmonary diseases in patients with RA.
During one year, patients with a RA diagnosis (according to the criteria of the American Society of Rheumatology) in the south of Belgium will be enrolled on a voluntary basis. If available, data including quality of life and symptoms questionnaires, medical examinations, 6-minute walk-tests, pulmonary function tests and chest CT will be collected during two years.
Furthermore, patients could be included (if available data) in two additional sub-cohorts:
- "RAIDbio" sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers;
- "RAIDomix" sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest).
Due to a non-specific and poor clinical expression at beginning, there is currently an under-diagnosis of rheumatoid arthritis associated-interstitial lung disease (RA-ILD) at an early stage and we assume that an annual pneumological follow-up, search of early biomarkers and a radiomic approach of RA patients will overcome this issue. This should lead to a better follow-up and management (including the use of anti-fibrotic therapies in the future) of these patients and ultimately to a decrease in morbidity and mortality.
- Keywords
- rheumatoid arthritis, rheumatoid arthritis-associated interstitial lung disease, interstitial lung disease
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General cohort | Not described | |
| RAIDbio | Sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers | |
| RAIDomix | Sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and incidence
To determine real-life prevalence and incidence of lung diseases in all patients with RA in South of Belgium
Measured: 2-5 years
Secondary outcomes (4)
Early diagnosis
To diagnose RA-ILD at an earlier stage
Measured: 2-5 years
Morbidty/mortality
To decrease the morbidity and mortality associated with RA-ILD
Measured: 2-5 years
Biomarkers
To identify specific early biomarkers of RA-ILD
Measured: 2-5 years
Radiomics
To evaluate the prognosis value of radiomics approach in RA-ILD
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start20 Nov 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis-Associated Interstitial Lung DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Denis Anna, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184893
- Sponsor's protocol ID
- 2022/52
- Acronym
- RAID
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centric Prospective and Observational Study of Prevalence and Incidence of Interstitial Lung Diseases in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06184893
- Acronym / sponsor ID
- RAID / 2022/52
- Keywords
- rheumatoid arthritis, rheumatoid arthritis-associated interstitial lung disease, interstitial lung disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Dec 2023 (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.
This is a prospective multicenter study in southern Belgium to determine the prevalence and incidence of interstitial lung disease in patients with rheumatoid arthritis (RA).
Detailed description
This is a prospective multi-centric longitudinal study of the prevalence and incidence of pulmonary diseases in patients with RA.
During one year, patients with a RA diagnosis (according to the criteria of the American Society of Rheumatology) in the south of Belgium will be enrolled on a voluntary basis. If available, data including quality of life and symptoms questionnaires, medical examinations, 6-minute walk-tests, pulmonary function tests and chest CT will be collected during two years.
Furthermore, patients could be included (if available data) in two additional sub-cohorts:
- "RAIDbio" sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers;
- "RAIDomix" sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest).
Due to a non-specific and poor clinical expression at beginning, there is currently an under-diagnosis of rheumatoid arthritis associated-interstitial lung disease (RA-ILD) at an early stage and we assume that an annual pneumological follow-up, search of early biomarkers and a radiomic approach of RA patients will overcome this issue. This should lead to a better follow-up and management (including the use of anti-fibrotic therapies in the future) of these patients and ultimately to a decrease in morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General cohort | – | – |
| RAIDbio | – | –Sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers |
| RAIDomix | – | –Sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis visiting their rheumatologist in South of Belgium and willing to participate
Key inclusion criteria (5 listed)
- Diagnosis of rheumatoid arthritis according to the criteria of the American Society of Rheumatology
- Age > 18 years
- Willing to participate in the study and sign the informed consent form (ICF) of participants or their legal authorized representative
- RAIDbio subcohort : available data for one of the following analysis of biomarkers: volatile organic compounds, induced sputum or blood markers
- RAIDomix : available data for high resolution computed tomography of the chest
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and incidence
Time frame: 2-5 years
To determine real-life prevalence and incidence of lung diseases in all patients with RA in South of Belgium
4 secondary outcomes
Early diagnosis
Time frame: 2-5 years
Morbidty/mortality
Time frame: 2-5 years
Biomarkers
Time frame: 2-5 years
Radiomics
Time frame: 2-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis-Associated Interstitial Lung Disease, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Guiot, PhD (00324/323 7881, j.guiot@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and incidence (time frame: 2-5 years). 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 28 Dec 2023.