Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-11 @ 12:50 AM
Study NCT ID:
NCT03192267
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Rheumatoid Arthritis Lung Disease Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D008171', 'term': 'Lung Diseases'}], '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': 'Serum, plasma, and whole blood for RNA/DNA isolation will be obtained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Resolution Computed Tomography Chest Scan Results', 'timeFrame': 'Baseline (Visit 1 only)', 'description': 'A high resolution computed tomography (CT) chest scan will be done at visit 1 to evaluate the presence of lung disease.'}], 'secondaryOutcomes': [{'measure': 'Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Vital Capacity', 'timeFrame': 'Baseline and 1 year follow-up', 'description': 'Forced vital capacity (FVC), the total amount of air expelled after a deep breath, will be measured (liters) at baseline and 1-year follow-up. These values will be correlated with anti-malondialdehyde acetaldehyde (anti-MAA) antibodies, a novel biomarker for rheumatoid arthritis (RA).'}, {'measure': 'Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Expiratory Volume', 'timeFrame': 'Baseline and 1 year follow-up', 'description': 'Forced expiratory volume in 1 second (FEV1), the amount of air exhaled in a forced breath, will be measured (liters) at baseline and 1-year follow-up. These values will be correlated with anti-malondialdehyde acetaldehyde (anti-MAA) antibodies, a novel biomarker for rheumatoid arthritis (RA).'}, {'measure': 'Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Diffusion Lung Capacity of Carbon Monoxide', 'timeFrame': 'Baseline and 1 year follow-up', 'description': 'Diffusion lung capacity of carbon monoxide (DLCO), the efficiency of gas exchange in the lungs, will be measured (mL/min/mmHg) at baseline and 1-year follow-up. These values will be correlated with anti-malondialdehyde acetaldehyde (anti-MAA) antibodies, a novel biomarker for rheumatoid arthritis (RA).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['newly diagnosed rheumatoid arthritis', 'lung disease'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The goals of this study are to investigate and characterize lung disease and its prevalence in early RA participants. This will be done through pulmonary function and high resolution chest computed tomography (CT), questionnaires, and serum studies. Another goal is to find novel biomarkers, such anti-malondialdehyde-acetaldehyde (MAA) antibodies, as predictors of lung disease in RA participants.', 'detailedDescription': 'Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The purpose of this study is to characterize the prevalence and classification of lung disease in participants with newly diagnosed rheumatoid arthritis by prospectively gathering information on lung imaging and function, comorbidities and novel biomarkers, such as anti-malondialdehyde-acetaldehyde (MAA). Specifically, the study would determine whether (MAA) adduct antibody concentrations predict computed tomography (CT) changes consistent with RA-lung involvement and determine whether anti-MAA antibody concentrations predict pulmonary function abnormalities in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and diffusion lung capacity of carbon monoxide (DLCO). An additional goal is to develop a cohort of newly diagnosed RA patients who can be followed long-term through electronic medical record (EMR) surveys, and biobank samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'While new onset RA is more likely to occur in young to middle age adults, investigators would also like to study those with more long standing disease. In particular, older RA participants with cardiovascular disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19-90 years of age\n* Able to give informed consent\n* Diagnosis of RA by a Rheumatologist using 2010 American College of Rheumatology (ACR) criteria within the past 2 years\n\nExclusion Criteria:\n\n* Inflammatory arthritis that does not meet 2010 American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA)\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03192267', 'briefTitle': 'Early Rheumatoid Arthritis Lung Disease Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Early Rheumatoid Arthritis Lung Disease Study', 'orgStudyIdInfo': {'id': '0282-16-FB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment', 'description': 'No treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aimee B Schreiner, MS', 'role': 'CONTACT', 'email': 'aischreiner@unmc.edu', 'phone': '402-559-4873'}, {'name': 'Tina A Mahajan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bryant R England, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'centralContacts': [{'name': 'Aimee B Schreiner, MS', 'role': 'CONTACT', 'email': 'aischreiner@unmc.edu', 'phone': '402-559-4873'}, {'name': 'Bridget Kramer, RN', 'role': 'CONTACT', 'email': 'bridget.kramer@unmc.edu', 'phone': '402-559-7288'}], 'overallOfficials': [{'name': 'Tina D Mahajan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nebraska'}, {'name': 'Bryant R England, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}