Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
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
1 other identifier
observational
1,304
6 countries
28
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedStudy Start
First participant enrolled
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2025
CompletedNovember 12, 2025
November 1, 2025
1.6 years
May 3, 2023
November 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
up to 1 year
Prevalence of RA-ILD and radiological features of RA-ILD on HRCT
up to 1 year
Secondary Outcomes (7)
Demographics of patients with and without ILD symptoms
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide
up to 1 year
- +2 more secondary outcomes
Study Arms (1)
Patients with Rheumatoid Arthritis (RA)
RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD)
Eligibility Criteria
Patients with Rheumatoid Arthritis (RA) and 2 or more risk factors for developing Interstitial Lung Disease (ILD)
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Stanford University School of Medicine
Palo Alto, California, 94304, United States
University of Colorado
Aurora, Colorado, 80045, United States
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3025, United States
Clinique de l'infirmerie Protestante
Caluire-et-Cuire, 69300, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin
Paris, 75014, France
Hopital Bichat, APHP
Paris, 75018, France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, 18209, Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, 10117, Germany
Dr. Jochen Walter MD, Office Of
Rendsburg, 24768, Germany
Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological)
Genova, 16132, Italy
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
Milan, 20122, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124, Italy
AOU di Padova
Padua, 35128, Italy
Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore
Roma, 00168, Italy
Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, 37134, Italy
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital General Universitario De Valencia
Valencia, 46007, Spain
Hospital Do Meixoeiro
Vigo, 36200, Spain
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
Leeds University
West Yorkshire, LS2 9JT, United Kingdom
Southend University Hospital - Mid Essex Hospital Services NHS Trust
Westcliff-on-Sea, SS0 0RY, United Kingdom
Related Publications (1)
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.
PMID: 38773593DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 11, 2023
Study Start
November 27, 2023
Primary Completion
June 19, 2025
Study Completion
June 26, 2025
Last Updated
November 12, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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.