Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-14 @ 11:14 AM
Study NCT ID:
NCT02686320
Status:
TERMINATED
Last Update Posted:
2025-11-20
First Post:
2016-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study suspended due to lack of PI to handle it', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of severe infections', 'timeFrame': '5 years', 'description': 'Occurrence of severe infection requiring hospitalization or varicella-zoster virus'}, {'measure': 'Number of cancers', 'timeFrame': '5 years', 'description': 'Occurrence of solid cancer or hemopathy'}, {'measure': 'Number of cardiovascular diseases', 'timeFrame': '5 years', 'description': 'Occurrence of myocardial infarction or stroke'}, {'measure': 'Number of osteoporotic fractures', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Disease Activity Score (DAS 28)', 'timeFrame': '5 years', 'description': 'to evaluate articular activity'}, {'measure': 'Simple Disease Activity Index (SDAI)', 'timeFrame': '5 years', 'description': 'to evaluate clinical articular activity of rheumatoid arthritis'}, {'measure': 'Erythrocyte sedimentation rate', 'timeFrame': '5 years', 'description': 'to evaluate biological articular activity of rheumatoid arthritis'}, {'measure': 'Measure of C-reactive protein (CRP)', 'timeFrame': '5 years', 'description': 'to evaluate biological articular activity of rheumatoid arthritis'}, {'measure': 'Number of synovitis and/or tenosynovitis at ultrasound of hands', 'timeFrame': '5 years', 'description': 'to evaluate articular activity of rheumatoid arthritis at ultrasound'}, {'measure': 'Health assessment questionnaire (HAQ) score', 'timeFrame': '5 years'}, {'measure': 'Need of orthopaedic surgery', 'timeFrame': '5 years', 'description': 'to evaluate severity of rheumatoid arthritis'}, {'measure': 'Number of erosions at X-rays (hands and feet)', 'timeFrame': '5 years', 'description': 'to evaluate severity of rheumatoid arthritis'}, {'measure': 'Number of diabetes, arterial hypertension and dyslipidaemia', 'timeFrame': '5 years', 'description': 'to evaluate risks factor of cardiovascular disease'}, {'measure': 'Number of cataracts', 'timeFrame': '5 years'}, {'measure': 'Number of vaccinations', 'timeFrame': '5 years', 'description': 'Previous influenza vaccination within the previous year and pneumococcal vaccination within the previous 5 years will be searched during medical interview.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'Elderly', 'infections', 'cardio-vascular disease', 'osteoporosis', 'cancer'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '24105334', 'type': 'BACKGROUND', 'citation': 'Soubrier M, Tatar Z, Couderc M, Mathieu S, Dubost JJ. Rheumatoid arthritis in the elderly in the era of tight control. Drugs Aging. 2013 Nov;30(11):863-9. doi: 10.1007/s40266-013-0122-8.'}, {'pmid': '22833532', 'type': 'BACKGROUND', 'citation': 'Widdifield J, Bernatsky S, Paterson JM, Gunraj N, Thorne JC, Pope J, Cividino A, Bombardier C. Serious infections in a population-based cohort of 86,039 seniors with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Mar;65(3):353-61. doi: 10.1002/acr.21812.'}]}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) is associated with a higher prevalence of infections, malignancies, osteoporotic fractures and cardiovascular diseases. Few data are available regarding the prevalence and severity of these comorbidities in elderly RA patients. The purpose of this study is to determine the effect of age on prevalence and severity of comorbidities in RA.', 'detailedDescription': 'Prevalence of rheumatoid arthritis (RA) in elderly is increasing because of the increasing life expectancy. RA is associated with a higher prevalence of infections, malignancies, osteoporotic fractures and cardiovascular diseases. The purpose of this study is to determine the effect of age on prevalence and severity of comorbidities in RA. This study also aims to determine whether age influences disease progression and efficacy and tolerance of treatments.\n\nThis study will compare two groups of patients : patients older than 65 years old and patients younger than 50 years old, matched for gender and disease duration.\n\nThe first part of the study will be cross-sectional and will aim to compare characteristics regarding RA manifestations and comorbidities of the two groups at inclusion.\n\nWhereas the second part will be prospective to assess the occurrence of comorbidities and the efficacy and safety of treatments in these two groups. Patients will be assessed every year during 5 years in accordance with usual follow-up of the patients.\n\nThis study could help to better manage elderly RA patients and to modify clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rheumatoid arthritis patients from department A and B of rheumatology in Cochin hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Rheumatoid arthritis according to American College of Rheumatology (ACR) /Eular 2010 criteria or American College of Rheumatalogy 1987 criteria\n* Age \\>65 years or patients between 18 and 50 years matched for sex and disease duration with the group of elderly patients (control group)\n\nExclusion Criteria:\n\n* Patients who do not understand rules and implications of the study'}, 'identificationModule': {'nctId': 'NCT02686320', 'acronym': 'PRESAGE', 'briefTitle': 'Prospective Study of Patients With Rheumatoid Arthritis After the Age of 65', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old', 'orgStudyIdInfo': {'id': 'NI-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis >65 years old'}, {'label': 'Rheumatoid arthritis <50 years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Cochin hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Yannick ALLANORE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique- Hôpitaux de Paris, Cochin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}