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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05855109
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Italy, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid, Lung Diseases, Interstitial
Study Website: View Trial Website
Arms & Interventions

Arms

: Patients with Rheumatoid Arthritis (RA)

RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD)

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University School of Medicine, Palo Alto, California

Status

Recruiting

Address

Stanford University School of Medicine

Palo Alto, California, 94304

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

University of Colorado, Aurora, Colorado

Status

Recruiting

Address

University of Colorado

Aurora, Colorado, 80045

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Boston, Massachusetts

Status

Recruiting

Address

Harvard Medical School - Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

University of Michigan Health System, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Health System

Ann Arbor, Michigan, 48109

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3025

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

International Sites

Clinique de l'infirmerie Protestante, Caluire-et-Cuire, France

Status

Recruiting

Address

Clinique de l'infirmerie Protestante

Caluire-et-Cuire, , 69300

Site Contact

Boehringer Ingelheim

france@bitrialsupport.com

0805102354

Paris, France

Status

Recruiting

Address

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin

Paris, , 75014

Site Contact

Boehringer Ingelheim

france@bitrialsupport.com

0805102354

Hopital Bichat, APHP, Paris, France

Status

Recruiting

Address

Hopital Bichat, APHP

Paris, , 75018

Site Contact

Boehringer Ingelheim

france@bitrialsupport.com

0805102354

Saint Priest en Jarez, France

Status

Recruiting

Address

Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

Saint Priest en Jarez, , 42270

Site Contact

Boehringer Ingelheim

france@bitrialsupport.com

0805102354

Modena, Italy

Status

Recruiting

Address

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, , 41124

Site Contact

Boehringer Ingelheim

italia@bitrialsupport.com

800977373

Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore

Roma, , 00168

Site Contact

Boehringer Ingelheim

italia@bitrialsupport.com

800977373

Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Barcelona, , 08036

Site Contact

Boehringer Ingelheim

espana@bitrialsupport.com

900876092

Hospital Universitario Reina Sofia, Cordoba, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Cordoba, , 14004

Site Contact

Boehringer Ingelheim

espana@bitrialsupport.com

900876092

Hospital Universitario Ramon y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramon y Cajal

Madrid, , 28034

Site Contact

Boehringer Ingelheim

espana@bitrialsupport.com

900876092

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Valencia, Spain

Status

Active, not recruiting

Address

Hospital General Universitario De Valencia

Valencia, , 46007

Hospital Do Meixoeiro, Vigo, Spain

Status

Recruiting

Address

Hospital Do Meixoeiro

Vigo, , 36200

Site Contact

Boehringer Ingelheim

espana@bitrialsupport.com

900876092

Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham University Hospitals NHS Trust - Nottingham City Hospital

Nottingham, , NG5 1PB

Site Contact

Boehringer Ingelheim

unitedkingdom@bitrialsupport.com

08000514022

Southampton, United Kingdom

Status

Recruiting

Address

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Southampton, , SO16 6YD

Site Contact

Boehringer Ingelheim

unitedkingdom@bitrialsupport.com

08000514022

Leeds University, West Yorkshire, United Kingdom

Status

Recruiting

Address

Leeds University

West Yorkshire, , LS2 9JT

Site Contact

Boehringer Ingelheim

unitedkingdom@bitrialsupport.com

08000514022

Westcliff-On-Sea, United Kingdom

Status

Recruiting

Address

Southend University Hospital - Mid Essex Hospital Services NHS Trust

Westcliff-On-Sea, , SS0 0RY

Site Contact

Boehringer Ingelheim

unitedkingdom@bitrialsupport.com

08000514022