CompletedNot Applicable

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

United States1,304 participantsStarted 2023-11-27

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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):

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)

What they're measuring

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

Timeframe: up to 1 year

Prevalence of RA-ILD and radiological features of RA-ILD on HRCT

Timeframe: up to 1 year

Trial details

NCT IDNCT05855109

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-19

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