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OpenTrials
Completed

NCT Number: NCT05855109

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de l'infirmerie Protestante, Caluire-et-Cuire, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

    Time frame: up to 1 year

Secondary outcomes

  1. Demographics of patients with and without ILD symptoms

    Time frame: up to 1 year

    Age, sex, race (Baseline characteristics)

  2. Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis

    Time frame: up to 1 year

  3. Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28

    Time frame: 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

    Time frame: up to 1 year

  5. Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide

    Time frame: up to 1 year

  6. Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations

    Time frame: 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

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 11, 2023
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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