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

Last updated: April 3, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT05855109
1199-0510
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 anyRA 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/ORanti-cyclic citrullinated peptide (anti-CCP) high-positive (titer > 3x upperlimit of normal) at RA diagnosis or any time after RA diagnosis

  • High/severe RA disease activity score at screening visit or within 12 months ofscreening visit, as defined with any of the following measures: DiseaseActivity Score-28 (DAS-28), Clinical Disease Activity Index (CDAI), RoutineAssessment 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

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 beforescan)

  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-modifyingantirheumatic 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 syndromecoronavirus 2 (SARS-CoV-2) infection / coronavirus disease 19 (COVID-19) (based onInvestigators' judgement)

  8. Patients diagnosed with another autoimmune disorders overlapping with RA-associatedwith the development of ILD (systemic sclerosis, myositis, dermatomyositis, mixedconnective tissue disease, systemic lupus erythematosus, antineutrophiliccytoplasmic antibody (ANCA)-associated vasculitis or primary Sjogren's syndrome)

  9. Patients currently enrolled in an investigational new drug trial

Study Design

Total Participants: 1203
Study Start date:
November 27, 2023
Estimated Completion Date:
July 10, 2025

Connect with a study center

  • Clinique de l'infirmerie Protestante

    Caluire-et-Cuire, 69300
    France

    Site Not Available

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

    Paris, 75014
    France

    Site Not Available

  • Hopital Bichat, APHP

    Paris, 75018
    France

    Site Not Available

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

    Saint Priest en Jarez, 42270
    France

    Site Not Available

  • Rheumazentrum Prof. Dr. med Gunther Neeck

    Bad Doberan, 18209
    Germany

    Site Not Available

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

    Berlin, 10117
    Germany

    Site Not Available

  • Dr. Jochen Walter MD, Office Of

    Rendsburg, 24768
    Germany

    Site Not Available

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

    Genova, 16132
    Italy

    Site Not Available

  • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano

    Milan, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena, 41124
    Italy

    Site Not Available

  • AOU di Padova

    Padova, 35128
    Italy

    Site Not Available

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

    Roma, 00168
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma

    Verona, 37134
    Italy

    Site Not Available

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital General Universitario De Valencia

    Valencia, 46007
    Spain

    Site Not Available

  • Hospital Do Meixoeiro

    Vigo, 36200
    Spain

    Site Not Available

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Leeds University

    West Yorkshire, LS2 9JT
    United Kingdom

    Site Not Available

  • Southend University Hospital - Mid Essex Hospital Services NHS Trust

    Westcliff-On-Sea, SS0 0RY
    United Kingdom

    Site Not Available

  • Stanford University School of Medicine

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Harvard Medical School - Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198-3025
    United States

    Site Not Available

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