Arthritis, Rheumatoid, Lung Diseases, Interstitial
Conditions
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).
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Prevalence of RA-ILD and radiological features of RA-ILD on HRCT | up to 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity | up to 1 year | — |
| Demographics of patients with and without ILD symptoms | up to 1 year | Age, sex, race (Baseline characteristics) |
| 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. |
| Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings | up to 1 year | — |
| Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide | up to 1 year | — |
| Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis | up to 1 year | — |
Countries
France, Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed