NCT05855109Completed
Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
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
Source: ClinicalTrials.gov · Last updated 12 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1304 (actual)
- First submitted
- 3 May 2023
- Start date
- 27 Nov 2023
- Primary completion date
- 19 Jun 2025
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05855109
What you commit to
- Study type: Observational
- Participants enrolled: 1304
- From 27 Nov 2023 to the primary completion date, 19 Jun 2025
- 28 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously diagnosed with any ILD or interstitial lung abnormality (ILA)
- 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.
- Patients who have had a lung transplant
- Patients currently enrolled in an investigational new drug trial
Other illness
- 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)
- 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)
Other
- Patients who have had a chest computerized tomography (CT) in the past 2 years
- Pregnancy at time of HRCT (to be checked in women of child-bearing potential before scan)
- Unwilling or unable to obtain HRCT
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumazentrum Prof. Dr. med Gunther Neeck Coordinator of this site? Confirm its status | Bad Doberan | Germany | Unknown status |
| Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Dr. Jochen Walter MD, Office Of Coordinator of this site? Confirm its status | Rendsburg | Germany | Unknown status |
| Hospital Clinic de Barcelona (Hospital Clinic i Provincial) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Do Meixoeiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Clinique de l'infirmerie Protestante Coordinator of this site? Confirm its status | Caluire-et-Cuire | France | Unknown status |
| Hopital Bichat, APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Universitaire (CHU) de Saint-Étienne - Hôpital Nord Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Nottingham University Hospitals NHS Trust - Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Southampton General Hospital, University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Southend University Hospital - Mid Essex Hospital Services NHS Trust Coordinator of this site? Confirm its status | Westcliff-on-Sea | United Kingdom | Unknown status |
| Leeds University Coordinator of this site? Confirm its status | West Yorkshire | United Kingdom | Unknown status |
| Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological) Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Policlinico di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| AOU di Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| University of Michigan Health System Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Harvard Medical School, Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Stanford University, School of Medicine Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.