Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors

Completed

Conditions studied: Arthritis, Rheumatoid, Lung Diseases, Interstitial

In brief

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).

Key facts

Study ID

NCT05855109

Run by

Boehringer Ingelheim

People needed

1304

Starts

2023-11-27

Expected to finish

2025-06-26

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 — Padova, 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

Full record on ClinicalTrials.gov

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