Phase
Condition
Rheumatoid Arthritis
Joint Injuries
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 anyRA 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/ORanti-cyclic citrullinated peptide (anti-CCP) high-positive (titer > 3x upperlimit of normal) at RA diagnosis or any time after RA diagnosis
High/severe RA disease activity score at screening visit or within 12 months ofscreening visit, as defined with any of the following measures: DiseaseActivity Score-28 (DAS-28), Clinical Disease Activity Index (CDAI), RoutineAssessment 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
Exclusion criteria:
Patients previously diagnosed with any ILD or interstitial lung abnormality (ILA)
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 beforescan)
Unwilling or unable to obtain HRCT
Patients previously received drugs or treatments that are known to induce ILD (e.g.,radiation therapy to chest region, bleomycin). Note: All disease-modifyingantirheumatic drugs (DMARDs) including methotrexate and biologics are allowed.
Patients who have had a lung transplant
Patients suspected of having developed ILD due to severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) infection / coronavirus disease 19 (COVID-19) (based onInvestigators' judgement)
Patients diagnosed with another autoimmune disorders overlapping with RA-associatedwith the development of ILD (systemic sclerosis, myositis, dermatomyositis, mixedconnective tissue disease, systemic lupus erythematosus, antineutrophiliccytoplasmic antibody (ANCA)-associated vasculitis or primary Sjogren's syndrome)
Patients currently enrolled in an investigational new drug trial
Study Design
Connect with a study center
Clinique de l'infirmerie Protestante
Caluire-et-Cuire, 69300
FranceSite Not Available
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin
Paris, 75014
FranceSite Not Available
Hopital Bichat, APHP
Paris, 75018
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint Priest en Jarez, 42270
FranceSite Not Available
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, 18209
GermanySite Not Available
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, 10117
GermanySite Not Available
Dr. Jochen Walter MD, Office Of
Rendsburg, 24768
GermanySite Not Available
Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological)
Genova, 16132
ItalySite Not Available
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
Milan, 20122
ItalySite Not Available
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124
ItalySite Not Available
AOU di Padova
Padova, 35128
ItalySite Not Available
Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore
Roma, 00168
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, 37134
ItalySite Not Available
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 08036
SpainSite Not Available
Hospital Universitario Reina Sofia
Cordoba, 14004
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital General Universitario De Valencia
Valencia, 46007
SpainSite Not Available
Hospital Do Meixoeiro
Vigo, 36200
SpainSite Not Available
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, NG5 1PB
United KingdomSite Not Available
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United KingdomSite Not Available
Leeds University
West Yorkshire, LS2 9JT
United KingdomSite Not Available
Southend University Hospital - Mid Essex Hospital Services NHS Trust
Westcliff-On-Sea, SS0 0RY
United KingdomSite Not Available
Stanford University School of Medicine
Palo Alto, California 94304
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Harvard Medical School - Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
University of Michigan Health System
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198-3025
United StatesSite Not Available
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