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

NCT05855109

CompletedN/A

Sponsor: Boehringer Ingelheim

Conditions: Arthritis, Rheumatoid, Lung Diseases, Interstitial

Countries: United States, France, Germany, Italy, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (28)
  • Palo Alto, California, United States
  • Aurora, Colorado, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Omaha, Nebraska, United States
  • Caluire-et-Cuire, France
  • Paris, France
  • Paris, France
  • Saint-Priest-en-Jarez, France
  • Bad Doberan, Germany
  • Berlin, Germany
  • Rendsburg, Germany
  • Genova, Italy
  • Milan, Italy
  • Modena, Italy
  • Padova, Italy
  • Roma, Italy
  • Verona, Italy
  • Barcelona, Spain
  • Córdoba, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Valencia, Spain
  • Vigo, Spain
  • Nottingham, United Kingdom
  • Southampton, United Kingdom
  • West Yorkshire, United Kingdom
  • Westcliff-on-Sea, United Kingdom