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NCT05855109Completed

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

Source: ClinicalTrials.gov · Last updated 12 Nov 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
1304 (actual)
First submitted
3 May 2023
Start date
27 Nov 2023
Primary completion date
19 Jun 2025
Lead sponsor
Boehringer Ingelheim
NCT number
NCT05855109

What you commit to

  • Study type: Observational
  • Participants enrolled: 1304
  • From 27 Nov 2023 to the primary completion date, 19 Jun 2025
  • 28 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients previously diagnosed with any ILD or interstitial lung abnormality (ILA)
  • 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 currently enrolled in an investigational new drug trial

Other illness

  • 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)

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rheumazentrum Prof. Dr. med Gunther Neeck
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Bad DoberanGermanyUnknown status
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
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BerlinGermanyUnknown status
Dr. Jochen Walter MD, Office Of
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RendsburgGermanyUnknown status
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
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BarcelonaSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital General Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Do Meixoeiro
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VigoSpainUnknown status
Clinique de l'infirmerie Protestante
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Caluire-et-CuireFranceUnknown status
Hopital Bichat, APHP
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ParisFranceUnknown status
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin
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ParisFranceUnknown status
Centre Hospitalier Universitaire (CHU) de Saint-Étienne - Hôpital Nord
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Saint-Priest-en-JarezFranceUnknown status
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
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SouthamptonUnited KingdomUnknown status
Southend University Hospital - Mid Essex Hospital Services NHS Trust
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Westcliff-on-SeaUnited KingdomUnknown status
Leeds University
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West YorkshireUnited KingdomUnknown status
Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological)
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GenovaItalyUnknown status
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
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MilanItalyUnknown status
Azienda Ospedaliero-Universitaria Policlinico di Modena
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ModenaItalyUnknown status
AOU di Padova
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PadovaItalyUnknown status
Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore
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RomaItalyUnknown status
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
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VeronaItalyUnknown status
University of Michigan Health System
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Ann ArborUnited StatesUnknown status
University of Colorado
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AuroraUnited StatesUnknown status
Harvard Medical School, Brigham and Women's Hospital
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BostonUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Stanford University, School of Medicine
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Palo AltoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.