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

Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting ID

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Time Perspective:
    Official Title:
    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
    Anticipated Study Start Date :
    Sep 5, 2023
    Anticipated Primary Completion Date :
    Sep 5, 2024
    Anticipated Study Completion Date :
    Sep 5, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Rheumatoid Arthritis (RA)

    RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD)

    Outcome Measures

    Primary Outcome Measures

    1. Probability score based on multi-variable diagnostic model that incorporates risk factors commonly available in clinical practice for RA-ILD screening [up to 1 year]

      The endpoint of the model will be to recommend screening HRCT scan based on risk factors.

    2. Prevalence of RA-ILD and radiological features of RA-ILD on HRCT [up to 1 year]

    Secondary Outcome Measures

    1. Demographics of patients with and without ILD symptoms [up to 1 year]

      Age, sex, race (Baseline characteristics)

    2. Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis [up to 1 year]

    3. Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28 [up to 1 year]

      The DAS28 score ranges from 0 to 9.4 with higher values reflecting a higher disease activity.

    4. Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity [up to 1 year]

    5. Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide [up to 1 year]

    6. Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations [up to 1 year]

      The overall apparent performance of the model will primarily be assessed using the Brier Score. Discrimination will be assessed using the Area Under the Curve (AUC) (c-statistic) and callibration will be analysed with a calibration plot.

    7. Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings [up to 1 year]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    None provided.
    Responsible Party:
    Boehringer Ingelheim Identifier:
    Other Study ID Numbers:
    • 1199-0510
    First Posted:
    May 11, 2023
    Last Update Posted:
    May 17, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 17, 2023