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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855109
• Other study ID #: 1199-0510
• Status: Recruiting
• Start date: October 17, 2023
• Est. completion date: May 28, 2025

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 28, 2025
• Est. primary completion date: May 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
France	Clinique de l'infirmerie Protestante	Caluire-et-Cuire
France	Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin	Paris
France	Hopital Bichat, APHP	Paris
France	Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord	Saint Priest en Jarez
Italy	Azienda Ospedaliero-Universitaria Policlinico di Modena	Modena
Italy	Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore	Roma
Spain	Hospital Clinic de Barcelona (Hospital Clinic i Provincial)	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital General Universitario De Valencia	Valencia
Spain	Hospital Do Meixoeiro	Vigo
United Kingdom	Nottingham University Hospitals NHS Trust - Nottingham City Hospital	Nottingham
United Kingdom	Southampton General Hospital - University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	Leeds University	West Yorkshire
United Kingdom	Southend University Hospital - Mid Essex Hospital Services NHS Trust	Westcliff-On-Sea
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Harvard Medical School - Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability score based on multi-variable diagnostic model that incorporates risk factors commonly available in clinical practice for RA-ILD screening	The endpoint of the model will be to recommend screening HRCT scan based on risk factors.	up to 1 year
Primary	Prevalence of RA-ILD and radiological features of RA-ILD on HRCT		up to 1 year
Secondary	Demographics of patients with and without ILD symptoms	Age, sex, race (Baseline characteristics)	up to 1 year
Secondary	Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis		up to 1 year
Secondary	Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28	The DAS28 score ranges from 0 to 9.4 with higher values reflecting a higher disease activity.	up to 1 year
Secondary	Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity		up to 1 year
Secondary	Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide		up to 1 year
Secondary	Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations	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.	up to 1 year
Secondary	Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings		up to 1 year

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