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

April 22, 2024 updated by: Boehringer Ingelheim

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

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caluire-et-Cuire, France, 69300
        • Recruiting
        • Clinique de l'infirmerie Protestante
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin
        • Contact:
      • Paris, France, 75018
      • Saint Priest en Jarez, France, 42270
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
        • Contact:
  • Italy
      • Modena, Italy, 41124
        • Recruiting
        • Azienda Ospedaliero-Universitaria Policlinico di Modena
        • Contact:
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore
        • Contact:
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
        • Contact:
      • Cordoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Active, not recruiting
        • Hospital Universitario 12 De Octubre
      • Valencia, Spain, 46007
        • Active, not recruiting
        • Hospital General Universitario de Valencia
      • Vigo, Spain, 36200
  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham University Hospitals NHS Trust - Nottingham City Hospital
        • Contact:
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
        • Contact:
      • West Yorkshire, United Kingdom, LS2 9JT
      • Westcliff-On-Sea, United Kingdom, SS0 0RY
        • Recruiting
        • Southend University Hospital - Mid Essex Hospital Services NHS Trust
        • Contact:
  • United States
    • California
      • Palo Alto, California, United States, 94304
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Harvard Medical School - Brigham and Women's Hospital
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Rheumatoid Arthritis (RA) and 2 or more risk factors for developing Interstitial Lung Disease (ILD)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Rheumatoid Arthritis (RA)
RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probability score based on multi-variable diagnostic model that incorporates risk factors commonly available in clinical practice for RA-ILD screening
Time Frame: up to 1 year
The endpoint of the model will be to recommend screening HRCT scan based on risk factors.
up to 1 year
Prevalence of RA-ILD and radiological features of RA-ILD on HRCT
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics of patients with and without ILD symptoms
Time Frame: up to 1 year
Age, sex, race (Baseline characteristics)
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis
Time Frame: up to 1 year
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28
Time Frame: up to 1 year
The DAS28 score ranges from 0 to 9.4 with higher values reflecting a higher disease activity.
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity
Time Frame: up to 1 year
up to 1 year
Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide
Time Frame: up to 1 year
up to 1 year
Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings
Time Frame: up to 1 year
up to 1 year
Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations
Time Frame: 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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

May 28, 2025

Study Completion (Estimated)

May 28, 2025

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Estimated)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1199-0510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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