Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 12:19 PM
Study NCT ID:
NCT04227535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-28
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood DNA, blood mRNA, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 509}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).', 'timeFrame': 'Baseline', 'description': 'whole exome sequencing data'}], 'secondaryOutcomes': [{'measure': 'Identification of genetic factors implicated in RA-ILD using genome wide association study.', 'timeFrame': 'Baseline', 'description': 'genome wide sequencing data'}, {'measure': 'Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.', 'timeFrame': 'Every year during 5 years', 'description': 'Decline of pulmonary functional tests (PFT) as well as changes in High-Resolution Computed-Tomography chest scan scores'}, {'measure': 'Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.', 'timeFrame': 'Every year during 5 years', 'description': 'Influence of treatment (DMARDs and biologics) over RA-ILD course estimated annually given the cumulated dosage received.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Interstitial lung disease'], 'conditions': ['Rheumatoid Arthritis', 'Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).', 'detailedDescription': 'This is not an interventional study. This is a study designed to recruit individuals affected by RA and investigate associated ILD to better understand the clinical phenotypes and genetic/molecular endotypes of RAILD, including the prognosis of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population of interest are individuals affected by RA with ILD (RA-ILD). Individuals affected with RA and without ILD (RA-noILD) will be included as a control population. The ILD status being systematically assessed by HRCT chest scan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'SELECTION OF CASES :\n\nInclusion Criteria:\n\n* Age ≥18 years\n* RA diagnosis according to ACR (classification of rheumatoid arthritis) 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist\n* ILD diagnosis based on typical High-Resolution Computed-Tomography (HCRT) patterns and pulmonary function tests (PFT), validated by a senior pulmonologist\n\nExclusion Criteria:\n\n\\- Lack of signed informed consent\n\nSELECTION OF CONTROLS:\n\nInclusion Criteria:\n\n* Age ≥18 years\n* RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist\n\nExclusion Criteria:\n\n\\- Lack of signed informed consent'}, 'identificationModule': {'nctId': 'NCT04227535', 'acronym': 'TRANSLATE2', 'briefTitle': 'Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2', 'orgStudyIdInfo': {'id': 'K170801J'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis - Interstitial lung disease patients', 'description': 'Assessment are as follows :\n\n1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment)\n2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance\n3. Radiologic: chest HRCT scan\n4. Genetic: DNA, mRNA\n5. Biologic: serum'}, {'label': 'Rheumatoid arthritis - no Interstitial lung disease patients', 'description': 'Assessment are as follows :\n\n1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment)\n2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance\n3. Radiologic: chest HRCT scan\n4. Genetic: DNA, mRNA\n5. Biologic: serum'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Bichat Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Philippe DIEUDE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}