Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05269069
Status:
TERMINATED
Last Update Posted:
2024-05-16
First Post:
2022-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015519', 'term': 'Bone Density'}], 'ancestors': [{'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The sponsor decided to stop financing the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of visceral adiposity (VAT) in cm² at inclusion.', 'timeFrame': 'Baseline', 'description': 'A whole body composition acquisition by dual energy x-ray absorptiometry (DXA) will calculate visceral adiposity'}], 'secondaryOutcomes': [{'measure': 'Measures of lean body mass (LBM) in kg', 'timeFrame': 'Baseline'}, {'measure': 'Measures of total body fat (TBF) in %', 'timeFrame': 'Baseline'}, {'measure': 'Bone mineral density (BMD) measurements (in mg/cm²) at the lumbar spine (L1-L4) and total non-dominant hip', 'timeFrame': 'Baseline'}, {'measure': 'Measurements of bone remodeling markers (CTX and P1NP)', 'timeFrame': 'Baseline'}, {'measure': 'Level of Leptin', 'timeFrame': 'Baseline'}, {'measure': 'Measurement of bone marrow adiposity (in %) at the lumbar spine', 'timeFrame': 'Baseline'}, {'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body composition', 'rheumatoid arthritis', 'visceral adiposity', 'marrow adiposity', 'bone mineral density'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'During rheumatoid arthritis (RA) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass.\n\nDetermination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular (excess cardiovascular risk), metabolic (insulin resistance, diabetes and dyslipidemia) and bone (increased fracture risk) risks associated with this endocrine organ. Moreover, we do not have data concerning medullary adiposity in RA.\n\nThis pilot case-control study will be compare body composition, bone marrow adiposity and bone mineral density in patients with RA versus healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheumatoid arthritis and controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects:\n\nMales and females of age (age ≥ 18 years). Patients with RA according to American College of Rheumatology/EULAR 2010 criteria, Patients who have signed the informed consent\n\nControls:\n\nMales and females of age (age ≥ 18 years). subjects who have signed the informed consent\n\nExclusion Criteria:\n\n* Patients who have received more than three anti-TNFinhibitors\n* Patients who have previously received a Janus kinase (JAK) inhibitor\n* Patients with concomitant therapies as described below :\n\nA combination with methotrexate is allowed if methotrexate is started ≥3 months before the start of the study and at a stable dosage (≤25 mg/week) for ≥4 weeks.\n\nA combination to conventional synthetic DMARDs (csDMARDs) other than methotrexate is not allowed within 4 weeks before and/or during the clinical trial\n\n* Corticosteroid therapy \\>10mg/d prednisolone equivalent is not allowed\n* Intra-articular injections of corticosteroids are allowed if their number is less than or equal to 4\n* Intravenous corticosteroid infusions are not allowed\n* Immunosuppressants other than methotrexate are not allowed\n* History or discovery of an osteoporotic fracture AND/OR T-score ≤-3 if ≥50 years old AND/OR Z-score ≤-3 if \\<50 years old during the screening phase,\n* Corticosteroid therapy ≥ 10mg/d prednisolone equivalent,\n* Pathologies or treatments affecting bone metabolism (breast cancer with antiaromatase, digestive malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...),\n* History of radiotherapy on the lumbar spine or the hip studied,\n* Patients undergoing hormone replacement therapy (HRT) or patients already under anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide or denosumab) apart from calcium and/or vitamin D supplementation, Chronic renal failure with creatinine clearance (CKD-EPI formula) ≤ 30 ml/min,'}, 'identificationModule': {'nctId': 'NCT05269069', 'acronym': 'RAFAT', 'briefTitle': 'Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study', 'orgStudyIdInfo': {'id': '2021_0845'}, 'secondaryIdInfos': [{'id': '2021-A03187-34', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with rheumatoid arthritis', 'description': 'patients with rheumatoid arthritis', 'interventionNames': ['Other: Assessment of body composition, bone mineral density and bone marrow adiposity.']}, {'label': 'Control group', 'description': 'healthy volunteers without rheumatoid arthritis matched for age, sex, BMI and menopausal status', 'interventionNames': ['Other: Assessment of body composition, bone mineral density and bone marrow adiposity.']}], 'interventions': [{'name': 'Assessment of body composition, bone mineral density and bone marrow adiposity.', 'type': 'OTHER', 'description': 'DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP)', 'armGroupLabels': ['Control group', 'Patients with rheumatoid arthritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hop Salengro - Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Jean-Guillaume LETARTOUILLY, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}