Arthritis, RheumatoidNCT05855109
Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
An observational study of Arthritis, Rheumatoid and Lung Diseases, Interstitial, run by Boehringer Ingelheim at 28 sites in 6 countries.
Trial summary
The overall aim of the study is to develop and validate a Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) clinical prediction model (screening tool) based on risk factors to guide screening for ILD in patients with RA using High Resolution Computed Tomography (HRCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
- How many people
- 1,304 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 27 Nov 2023to 26 Jun 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Rheumatoid Arthritis (RA) and 2 or more risk factors for developing Interstitial Lung Disease (ILD)
Who may be able to join
- Adult patients with RA according to 1987 American College of Rheumatology (ACR) or 2010 ACR / European League Against Rheumatism (EULAR) classification of RA, with any RA duration
- Patient must have ≥ 2 of the following risk factors for ILD (i.e., any 2 or more):
- Male
- Current or previous smoker
- Age of ≥ 60 years at RA diagnosis
- Rheumatoid factor high-positive (titer > 3x upper limit of normal) AND/OR anti-cyclic citrullinated peptide (anti-CCP) high-positive (titer > 3x upper limit of normal) at RA diagnosis or any time after RA diagnosis
- High/severe RA disease activity score at screening visit or within 12 months of screening visit, as defined with any of the following measures: Disease Activity Score-28 (DAS-28), Clinical Disease Activity Index (CDAI), Routine Assessment of Patient Index Data 3 (RAPID-3), Simple Disease Activity Index (SDAI), Patient Activity Scale (PAS), PAS-II
- Presence or history of these extra-articular manifestations of RA: vasculitis, Felty's syndrome, secondary Sjogren's syndrome, cutaneous rheumatoid nodules, serositis and/or scleritis/uveitis
Who cannot join
- Patients previously diagnosed with any ILD or interstitial lung abnormality (ILA)
- Patients who have had a chest computerized tomography (CT) in the past 2 years
- Pregnancy at time of HRCT (to be checked in women of child-bearing potential before scan)
- Unwilling or unable to obtain HRCT
- Patients previously received drugs or treatments that are known to induce ILD (e.g., radiation therapy to chest region, bleomycin). Note: All disease-modifying antirheumatic drugs (DMARDs) including methotrexate and biologics are allowed.
- Patients who have had a lung transplant
Show all 9Show fewer
- Patients suspected of having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection / coronavirus disease 19 (COVID-19) (based on Investigators' judgement)
- Patients diagnosed with another autoimmune disorders overlapping with RA-associated with the development of ILD (systemic sclerosis, myositis, dermatomyositis, mixed connective tissue disease, systemic lupus erythematosus, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis or primary Sjogren's syndrome)
- Patients currently enrolled in an investigational new drug trial
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
Italy6 sites
Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological)
Genova, 16132
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
Milan, 20122
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124
AOU di Padova
Padova, 35128
Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore
Roma, 00168
Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, 37134
Spain6 sites
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 08036
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital General Universitario De Valencia
Valencia, 46007
Hospital Do Meixoeiro
Vigo, 36200
United States5 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3025
Stanford University School of Medicine
Palo Alto, California, 94304
France4 sites
Clinique de l'infirmerie Protestante
Caluire-et-Cuire, 69300
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin
Paris, 75014
Hopital Bichat, APHP
Paris, 75018
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270
United Kingdom4 sites
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, NG5 1PB
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Leeds University
West Yorkshire, LS2 9JT
Southend University Hospital - Mid Essex Hospital Services NHS Trust
Westcliff-on-Sea, SS0 0RY
Germany3 sites
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, 18209
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, 10117
Dr. Jochen Walter MD, Office Of
Rendsburg, 24768
About this study
Official title: A Prospective, Multi-national, Cross-sectional Study on a Risk-factor Guided Approach to Interstitial Lung Disease Screening in Patients With Rheumatoid Arthritis at Higher Risk for ILD Using High Resolution Computed Tomography
The overall aim of the study is to develop and validate a Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) clinical prediction model (screening tool) based on risk factors to guide screening for ILD in patients with RA using High Resolution Computed Tomography (HRCT).
- Conditions
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
- 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 |
|---|---|---|
| Patients with Rheumatoid Arthritis (RA) | RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability score based on multi-variable diagnostic model that incorporates risk factors commonly available in clinical practice for RA-ILD screening
The endpoint of the model will be to recommend screening HRCT scan based on risk factors.
Measured: up to 1 year
Prevalence of RA-ILD and radiological features of RA-ILD on HRCT
Measured: up to 1 year
Secondary outcomes (7)
Demographics of patients with and without ILD symptoms
Age, sex, race (Baseline characteristics)
Measured: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis
Measured: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28
The DAS28 score ranges from 0 to 9.4 with higher values reflecting a higher disease activity.
Measured: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity
Measured: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide
Measured: up to 1 year
Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations
The overall apparent performance of the model will primarily be assessed using the Brier Score. Discrimination will be assessed using the Area Under the Curve (AUC) (c-statistic) and callibration will be analysed with a calibration plot.
Measured: up to 1 year
Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start27 Nov 2023
- Primary completion19 Jun 2025
- Study completion26 Jun 2025
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 Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855109
- Sponsor's protocol ID
- 1199-0510
- Status last verified
- Nov 2025
- First submitted
- 3 May 2023
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Publications
Sparks JA, Dieude P, Hoffmann-Vold AM, Burmester GR, Walsh SL, Kreuter M, Stock C, Sambevski S, Alves M, Emery P. Design of ANCHOR-RA: a multi-national cross-sectional study on screening for interstitial lung disease in patients with rheumatoid arthritis. BMC Rheumatol. 2024 May 21;8(1):19. doi: 10.1186/s41927-024-00389-4.
PubMed 38773593
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-national, Cross-sectional Study on a Risk-factor Guided Approach to Interstitial Lung Disease Screening in Patients With Rheumatoid Arthritis at Higher Risk for ILD Using High Resolution Computed Tomography
- ClinicalTrials.gov ID
- NCT05855109
- Acronym / sponsor ID
- 1199-0510
- Conditions
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,304 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 11 May 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.
The overall aim of the study is to develop and validate a Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) clinical prediction model (screening tool) based on risk factors to guide screening for ILD in patients with RA using High Resolution Computed Tomography (HRCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Rheumatoid Arthritis (RA) | – | –RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Rheumatoid Arthritis (RA) and 2 or more risk factors for developing Interstitial Lung Disease (ILD)
Key inclusion criteria (8 listed)
- Adult patients with RA according to 1987 American College of Rheumatology (ACR) or 2010 ACR / European League Against Rheumatism (EULAR) classification of RA, with any RA duration
- Patient must have ≥ 2 of the following risk factors for ILD (i.e., any 2 or more):
Key exclusion criteria (9 listed)
- Patients previously diagnosed with any ILD or interstitial lung abnormality (ILA)
- Patients who have had a chest computerized tomography (CT) in the past 2 years
- Pregnancy at time of HRCT (to be checked in women of child-bearing potential before scan)
- Unwilling or unable to obtain HRCT
- Patients previously received drugs or treatments that are known to induce ILD (e.g., radiation therapy to chest region, bleomycin). Note: All disease-modifying antirheumatic drugs (DMARDs) including methotrexate and biologics are allowed.
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
Probability score based on multi-variable diagnostic model that incorporates risk factors commonly available in clinical practice for RA-ILD screening
Time frame: up to 1 year
The endpoint of the model will be to recommend screening HRCT scan based on risk factors.
Prevalence of RA-ILD and radiological features of RA-ILD on HRCT
Time frame: up to 1 year
7 secondary outcomes
Demographics of patients with and without ILD symptoms
Time frame: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis
Time frame: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28
Time frame: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity
Time frame: up to 1 year
Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide
Time frame: up to 1 year
Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations
Time frame: up to 1 year
Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Derived from this study: PubMed 38773593Sparks JA, Dieude P, Hoffmann-Vold AM, Burmester GR, Walsh SL, Kreuter M, Stock C, Sambevski S, Alves M, Emery P. Design of ANCHOR-RA: a multi-national cross-sectional study on screening for interstitial lung disease in patients with rheumatoid arthritis. BMC Rheumatol. 2024 May 21;8(1):19. doi: 10.1186/s41927-024-00389-4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Lung Diseases, Interstitial, run by Boehringer Ingelheim at 28 sites in 6 countries.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, Spain, United States, France, United Kingdom and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Probability score based on multi-variable diagnostic model that incorporates risk factors commonly available in clinical practice for RA-ILD screening (time frame: up to 1 year). The study lists 2 primary outcomes in all. 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 NCT05855109, 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 12 Nov 2025.