Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
NCT ID: NCT05855109
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1304 participants
OBSERVATIONAL
2023-11-27
2025-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with Rheumatoid Arthritis (RA)
RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
Exclusion Criteria
2. Patients who have had a chest computerized tomography (CT) in the past 2 years
3. Pregnancy at time of HRCT (to be checked in women of child-bearing potential before scan)
4. Unwilling or unable to obtain HRCT
5. 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.
6. Patients who have had a lung transplant
7. 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)
8. 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)
9. Patients currently enrolled in an investigational new drug trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University School of Medicine
Palo Alto, California, United States
University of Colorado
Aurora, Colorado, United States
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Clinique de l'infirmerie Protestante
Caluire-et-Cuire, , France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin
Paris, , France
Hopital Bichat, APHP
Paris, , France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, , France
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, , Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, , Germany
Dr. Jochen Walter MD, Office Of
Rendsburg, , Germany
Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological)
Genova, , Italy
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
Milan, , Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, , Italy
AOU di Padova
Padua, , Italy
Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, , Italy
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital General Universitario De Valencia
Valencia, , Spain
Hospital Do Meixoeiro
Vigo, , Spain
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, , United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Leeds University
West Yorkshire, , United Kingdom
Southend University Hospital - Mid Essex Hospital Services NHS Trust
Westcliff-on-Sea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1199-0510
Identifier Type: -
Identifier Source: org_study_id