Clinical trial NCT05855109: Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthritis, Rheumatoid
Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-05-11
Enrollment: 1203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Rheumatoid Arthritis (RA) and 2 or more risk factors for developing Interstitial Lung Disease (ILD)

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).


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

Primary outcomes:
measure: 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
measure: Prevalence of RA-ILD and radiological features of RA-ILD on HRCT
timeFrame: up to 1 year
Secondary outcomes:
measure: Demographics of patients with and without ILD symptoms
timeFrame: up to 1 year
measure: Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis
timeFrame: up to 1 year
measure: Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28
timeFrame: up to 1 year
measure: Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity
timeFrame: up to 1 year
measure: Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide
timeFrame: up to 1 year
measure: Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations
timeFrame: up to 1 year
measure: Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Boston
country: United States
facility: Harvard Medical School - Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Caluire-et-Cuire
country: France
facility: Clinique de l'infirmerie Protestante
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin
city: Paris
country: France
facility: Hopital Bichat, APHP
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
city: Bad Doberan
country: Germany
facility: Rheumazentrum Prof. Dr. med Gunther Neeck
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
city: Rendsburg
country: Germany
facility: Dr. Jochen Walter MD, Office Of
city: Genova
country: Italy
facility: Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological)
city: Milan
country: Italy
facility: Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Modena
city: Padova
country: Italy
facility: AOU di Padova
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital General Universitario De Valencia
city: Vigo
country: Spain
facility: Hospital Do Meixoeiro
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Nottingham City Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
city: West Yorkshire
country: United Kingdom
facility: Leeds University
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital - Mid Essex Hospital Services NHS Trust
Study officials:
References: