Rheumatoid ArthritisTRANSLATE2NCT04227535
Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2
An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) 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, Interstitial Lung Disease
- How many people
- 509 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2020to 1 Oct 2027
- Phase
- Observational
- 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
Study population: The population of interest are individuals affected by RA with ILD (RA-ILD). Individuals affected with RA and without ILD (RA-noILD) will be included as a control population. The ILD status being systematically assessed by HRCT chest scan.
Who may be able to join
- Age ≥18 years
- RA diagnosis according to ACR (classification of rheumatoid arthritis) 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
- ILD diagnosis based on typical High-Resolution Computed-Tomography (HCRT) patterns and pulmonary function tests (PFT), validated by a senior pulmonologist
- Age ≥18 years
- RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
Who cannot join
- Lack of signed informed consent
- SELECTION OF CONTROLS:
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).
Read the detailed description
This is not an interventional study. This is a study designed to recruit individuals affected by RA and investigate associated ILD to better understand the clinical phenotypes and genetic/molecular endotypes of RAILD, including the prognosis of the disease.
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Keywords
- Rheumatoid Arthritis, 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 |
|---|---|---|
| Rheumatoid arthritis - Interstitial lung disease patients | Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum | |
| Rheumatoid arthritis - no Interstitial lung disease patients | Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).
whole exome sequencing data
Measured: Baseline
Secondary outcomes (3)
Identification of genetic factors implicated in RA-ILD using genome wide association study.
genome wide sequencing data
Measured: Baseline
Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.
Decline of pulmonary functional tests (PFT) as well as changes in High-Resolution Computed-Tomography chest scan scores
Measured: Every year during 5 years
Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.
Influence of treatment (DMARDs and biologics) over RA-ILD course estimated annually given the cumulated dosage received.
Measured: Every year during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start3 Feb 2020
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Philippe DIEUDE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227535
- Sponsor's protocol ID
- K170801J
- Acronym
- TRANSLATE2
- Status last verified
- Apr 2023
- First submitted
- 15 Jul 2019
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Juge PA, Debray MP, Pensec VD, Richez C, Avouac J, Wemeau-Stervinou L, Flipo RM, Nunes H, Saidenberg-Kermanac'h N, Gottenberg JE, Jouneau S, Constantin A, Cottin V, Marotte H, Soubrier M, Fautrel B, Nocturne G, Richette P, Berenbaum F, Zylberman-Yona H, Gorenne I, Bancal C, Borie R, Ebstein E, Forien M, Ottaviani S, Crestani B, Dieude P. Baseline characteristics of the TRANSLATE2 cohort: A prospective study on rheumatoid arthritis-associated interstitial lung disease. Joint Bone Spine. 2026 Mar;93(2):105991. doi: 10.1016/j.jbspin.2025.105991. Epub 2025 Oct 17.
PubMed 41110685
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2
- ClinicalTrials.gov ID
- NCT04227535
- Acronym / sponsor ID
- TRANSLATE2 / K170801J
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Keywords
- Rheumatoid Arthritis, Interstitial lung disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 Jan 2020 (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 overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).
Detailed description
This is not an interventional study. This is a study designed to recruit individuals affected by RA and investigate associated ILD to better understand the clinical phenotypes and genetic/molecular endotypes of RAILD, including the prognosis of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis - Interstitial lung disease patients | – | –Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum |
| Rheumatoid arthritis - no Interstitial lung disease patients | – | –Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of interest are individuals affected by RA with ILD (RA-ILD). Individuals affected with RA and without ILD (RA-noILD) will be included as a control population. The ILD status being systematically assessed by HRCT chest scan.
Key inclusion criteria (5 listed)
- Age ≥18 years
- RA diagnosis according to ACR (classification of rheumatoid arthritis) 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
- ILD diagnosis based on typical High-Resolution Computed-Tomography (HCRT) patterns and pulmonary function tests (PFT), validated by a senior pulmonologist
- Age ≥18 years
- RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
Key exclusion criteria (3 listed)
- Lack of signed informed consent
- Lack of signed informed consent
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
Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).
Time frame: Baseline
whole exome sequencing data
3 secondary outcomes
Identification of genetic factors implicated in RA-ILD using genome wide association study.
Time frame: Baseline
Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.
Time frame: Every year during 5 years
Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.
Time frame: Every year during 5 years
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 28 Apr 2023.
- Derived from this study: PubMed 41110685Juge PA, Debray MP, Pensec VD, Richez C, Avouac J, Wemeau-Stervinou L, Flipo RM, Nunes H, Saidenberg-Kermanac'h N, Gottenberg JE, Jouneau S, Constantin A, Cottin V, Marotte H, Soubrier M, Fautrel B, Nocturne G, Richette P, Berenbaum F, Zylberman-Yona H, Gorenne I, Bancal C, Borie R, Ebstein E, Forien M, Ottaviani S, Crestani B, Dieude P. Baseline characteristics of the TRANSLATE2 cohort: A prospective study on rheumatoid arthritis-associated interstitial lung disease. Joint Bone Spine. 2026 Mar;93(2):105991. doi: 10.1016/j.jbspin.2025.105991. Epub 2025 Oct 17.
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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.
Philippe DIEUDE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 and Interstitial Lung Disease, 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES). (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04227535, which also lists 1 linked publication.
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 Apr 2023.