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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Rheumatoid Arthritis (RA) | RA and 2 or more risk factors for developing Interstitial Lung Disease (ILD) |
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| 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 | 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 | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics of patients with and without ILD symptoms | Age, sex, race (Baseline characteristics) | up to 1 year |
| Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis |
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Inclusion criteria:
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):
Exclusion criteria:
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Patients with Rheumatoid Arthritis (RA) and 2 or more risk factors for developing Interstitial Lung Disease (ILD)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38773593 | Derived | Sparks JA, Dieude P, Hoffmann-Vold AM, Burmester GR, Walsh SL, Kreuter M, Stock C, Sambevski S, Alves M, Emery P. Design of ANCHOR-RA: a multi-national cross-sectional study on screening for interstitial lung disease in patients with rheumatoid arthritis. BMC Rheumatol. 2024 May 21;8(1):19. doi: 10.1186/s41927-024-00389-4. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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.
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| up to 1 year |
| 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 |
| Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity | up to 1 year |
| Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide | up to 1 year |
| 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 |
| Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings | up to 1 year |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Harvard Medical School - Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-3025 | United States |
| Clinique de l'infirmerie Protestante | Caluire-et-Cuire | 69300 | France |
| Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin | Paris | 75014 | France |
| Hopital Bichat, APHP | Paris | 75018 | France |
| Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Rheumazentrum Prof. Dr. med Gunther Neeck | Bad Doberan | 18209 | Germany |
| Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) | Berlin | 10117 | Germany |
| Dr. Jochen Walter MD, Office Of | Rendsburg | 24768 | Germany |
| Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological) | Genova | 16132 | Italy |
| Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano | Milan | 20122 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico di Modena | Modena | 41124 | Italy |
| AOU di Padova | Padova | 35128 | Italy |
| Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma | Verona | 37134 | Italy |
| Hospital Clinic de Barcelona (Hospital Clinic i Provincial) | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital General Universitario De Valencia | Valencia | 46007 | Spain |
| Hospital Do Meixoeiro | Vigo | 36200 | Spain |
| Nottingham University Hospitals NHS Trust - Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Southampton General Hospital - University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| Leeds University | West Yorkshire | LS2 9JT | United Kingdom |
| Southend University Hospital - Mid Essex Hospital Services NHS Trust | Westcliff-on-Sea | SS0 0RY | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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