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New screening tool aims to catch lung disease early in arthritis patients

NCT ID NCT05855109

Knowledge-focused Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involved 1304 adults with rheumatoid arthritis who had at least two risk factors for interstitial lung disease (ILD), such as being male, a smoker, or over 60. Researchers used CT scans to develop a prediction model that helps doctors decide who should be screened for ILD. The goal is to catch lung problems early in high-risk patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,304 people

The number who actually took part.

Started

Nov 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with Rheumatoid Arthritis (RA) and 2 or more risk factors for developing Interstitial Lung Disease (ILD)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. 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 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: 1. Patients previously diagnosed with any ILD or interstitial lung abnormality (ILA) 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

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Conditions

The condition(s) this trial relates to.

interstitial lung disease rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis rheumatoid Lung diseases, interstitial

Contacts and locations

Locations

  • AOU di Padova

    Padova, 35128, Italy

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin

    Paris, 75014, France

  • Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma

    Verona, 37134, Italy

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena, 41124, Italy

  • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42270, France

  • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117, Germany

  • Clinique de l'infirmerie Protestante

    Caluire-et-Cuire, 69300, France

  • Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological)

    Genova, 16132, Italy

  • Dr. Jochen Walter MD, Office Of

    Rendsburg, 24768, Germany

  • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore

    Roma, 00168, Italy

  • Harvard Medical School - Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Hopital Bichat, APHP

    Paris, 75018, France

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, 08036, Spain

  • Hospital Do Meixoeiro

    Vigo, 36200, Spain

  • Hospital General Universitario De Valencia

    Valencia, 46007, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Leeds University

    West Yorkshire, LS2 9JT, United Kingdom

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Rheumazentrum Prof. Dr. med Gunther Neeck

    Bad Doberan, 18209, Germany

  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • Southend University Hospital - Mid Essex Hospital Services NHS Trust

    Westcliff-on-Sea, SS0 0RY, United Kingdom

  • Stanford University School of Medicine

    Palo Alto, California, 94304, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3025, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.