Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-08 @ 3:44 AM
Study NCT ID:
NCT03616158
Status:
UNKNOWN
Last Update Posted:
2019-06-06
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'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': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'Interstitial Lung Disease', 'RA', 'ILD'], 'conditions': ['Rheumatoid Arthritis', 'Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.', 'detailedDescription': 'This study is to learn more about the risk factors for the development of lung disease among patients with rheumatoid arthritis (RA), an auto-immune disease. Additionally, those at heightened risk of developing RA such as in the pre-RA period. This is a prospective and retrospective study, which 420 patients will be enrolled into the study. In-person participation will be up to 4 years, completing different standard of care assessments yearly. Additionally, quality of life questionnaires will be completed every 6 months at 4 time points. Lastly, an extended follow-up will be performed yearly for an additional 6 years, an overall 10 year participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are selected for participation in the study because they are diagnosed with or without rheumatoid arthritis and lung disease.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Age 18 - 80 years\n\nExclusion Criteria:\n\n1. Subjects who do not speak English\n2. Subjects without the capacity to sign the informed consent form (ICF)\n3. Pregnant women'}, 'identificationModule': {'nctId': 'NCT03616158', 'acronym': 'RA-LD', 'briefTitle': 'Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time', 'organization': {'class': 'OTHER', 'fullName': 'National Jewish Health'}, 'officialTitle': 'Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease', 'orgStudyIdInfo': {'id': 'HS-3161'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-RA', 'description': 'Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and positive antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.\n\nIn-person Study Assessments Include:\n\n1. Medical History and Physical Exams\n2. Quality of Life Questionnaires\n3. Collection of blood\n4. Radiology\n5. Lung Function Test\n6. 6 Minute Walk Test\n7. Bronchoscopy (Clinically indicated)\n8. Sputum (Optional)\n9. Musculoskeletal ultrasound (Optional)'}, {'label': 'RA without LD', 'description': 'Subjects with rheumatoid arthritis (RA), and no interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.\n\nIn-person Study Assessments Include:\n\n1. Medical History and Physical Exams\n2. Quality of Life Questionnaires\n3. Collection of blood\n4. Radiology\n5. Lung Function Test\n6. 6 Minute Walk Test\n7. Bronchoscopy (Clinically indicated)\n8. Sputum (Optional)\n9. Musculoskeletal ultrasound (Optional)'}, {'label': 'RA-LD', 'description': 'Subjects with rheumatoid arthritis (RA) and interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.\n\nIn-person Study Assessments Include:\n\n1. Medical History and Physical Exams\n2. Quality of Life Questionnaires\n3. Collection of blood\n4. Radiology\n5. Lung Function Test\n6. 6 Minute Walk Test\n7. Bronchoscopy (Clinically indicated)\n8. Sputum (Optional)\n9. Musculoskeletal ultrasound (Optional)'}, {'label': 'LD Controls', 'description': 'Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and negative antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.\n\nIn-person Study Assessments Include:\n\n1. Medical History and Physical Exams\n2. Quality of Life Questionnaires\n3. Collection of blood\n4. Radiology\n5. Lung Function Test\n6. 6 Minute Walk Test\n7. Bronchoscopy (Clinically indicated)\n8. Sputum (Optional)\n9. Musculoskeletal ultrasound (Optional)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Faduma Ahmed, MPH', 'role': 'CONTACT', 'email': 'ahmedf@NJHealth.org', 'phone': '303-398-1285'}, {'name': 'Kristen M Demoruelle, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Mohning, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Isabelle Amigues, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Faduma Ahmed, MPH', 'role': 'CONTACT', 'email': 'ahmedf@NJHealth.org', 'phone': '303-398-1285'}, {'name': 'Jami Henriksen', 'role': 'CONTACT', 'email': 'henriksenj@NJHealth.org', 'phone': '303-398-1233'}], 'overallOfficials': [{'name': 'Joshua Solomon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Jewish Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}