Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 7:31 AM
Study NCT ID:
NCT06184893
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rheumatoid Arthritis-associated Interstitial Lung Disease Definition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence and incidence', 'timeFrame': '2-5 years', 'description': 'To determine real-life prevalence and incidence of lung diseases in all patients with RA in South of Belgium'}], 'secondaryOutcomes': [{'measure': 'Early diagnosis', 'timeFrame': '2-5 years', 'description': 'To diagnose RA-ILD at an earlier stage'}, {'measure': 'Morbidty/mortality', 'timeFrame': '2-5 years', 'description': 'To decrease the morbidity and mortality associated with RA-ILD'}, {'measure': 'Biomarkers', 'timeFrame': '2-5 years', 'description': 'To identify specific early biomarkers of RA-ILD'}, {'measure': 'Radiomics', 'timeFrame': '2-5 years', 'description': 'To evaluate the prognosis value of radiomics approach in RA-ILD'}]}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'rheumatoid arthritis-associated interstitial lung disease', 'interstitial lung disease'], 'conditions': ['Rheumatoid Arthritis-Associated Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective multicenter study in southern Belgium to determine the prevalence and incidence of interstitial lung disease in patients with rheumatoid arthritis (RA).', 'detailedDescription': 'This is a prospective multi-centric longitudinal study of the prevalence and incidence of pulmonary diseases in patients with RA.\n\nDuring one year, patients with a RA diagnosis (according to the criteria of the American Society of Rheumatology) in the south of Belgium will be enrolled on a voluntary basis. If available, data including quality of life and symptoms questionnaires, medical examinations, 6-minute walk-tests, pulmonary function tests and chest CT will be collected during two years.\n\nFurthermore, patients could be included (if available data) in two additional sub-cohorts:\n\n* "RAIDbio" sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers;\n* "RAIDomix" sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest).\n\nDue to a non-specific and poor clinical expression at beginning, there is currently an under-diagnosis of rheumatoid arthritis associated-interstitial lung disease (RA-ILD) at an early stage and we assume that an annual pneumological follow-up, search of early biomarkers and a radiomic approach of RA patients will overcome this issue. This should lead to a better follow-up and management (including the use of anti-fibrotic therapies in the future) of these patients and ultimately to a decrease in morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheumatoid arthritis visiting their rheumatologist in South of Belgium and willing to participate', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of rheumatoid arthritis according to the criteria of the American Society of Rheumatology\n* Age \\> 18 years\n* Willing to participate in the study and sign the informed consent form (ICF) of participants or their legal authorized representative\n* RAIDbio subcohort : available data for one of the following analysis of biomarkers: volatile organic compounds, induced sputum or blood markers\n* RAIDomix : available data for high resolution computed tomography of the chest\n\nExclusion Criteria: none'}, 'identificationModule': {'nctId': 'NCT06184893', 'acronym': 'RAID', 'briefTitle': 'Rheumatoid Arthritis-associated Interstitial Lung Disease Definition', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Liege'}, 'officialTitle': 'Multi-centric Prospective and Observational Study of Prevalence and Incidence of Interstitial Lung Diseases in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '2022/52'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General cohort'}, {'label': 'RAIDbio', 'description': 'Sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers'}, {'label': 'RAIDomix', 'description': 'Sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Julien Guiot', 'role': 'CONTACT', 'email': 'j.guiot@chuliege.be', 'phone': '00324/3237881'}, {'name': 'Anna Denis', 'role': 'CONTACT', 'email': 'anna.denis@chuliege.be', 'phone': '00324/3237881'}], 'facility': 'Centre Hospitalier Universitaire de Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Julien Guiot, PhD', 'role': 'CONTACT', 'email': 'j.guiot@chuliege.be', 'phone': '00324/323 7881'}, {'name': 'Anna Denis, MD', 'role': 'CONTACT', 'email': 'anna.denis@chulige.be', 'phone': '00324/323 7881'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Liege', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Denis Anna', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Liege'}}}}