Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-01 @ 7:27 AM
Study NCT ID:
NCT03076866
Status:
UNKNOWN
Last Update Posted:
2017-03-15
First Post:
2017-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Follow-up of Patients With Chronic Inflammatory Rheumatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D025241', 'term': 'Spondylarthritis'}], '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': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2001-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'evolution of BMD at 20 years of follow-up', 'timeFrame': '20 years', 'description': 'each 2 years during visit of follow up, BMD parameters (Hologic QDR 4500A measurements performed in pasteur 2 hospital: tscore, Zscore and BMD in in g/cm2) are collected. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis by a T-score below -2.5 SD, in accordance with the World Health Organization guidelines. evolution of BMD will be studied in relation with rheumatologics treatments'}], 'primaryOutcomes': [{'measure': 'therapeutic maintenance at 20 years of follow-up', 'timeFrame': '20 years', 'description': 'All subjects benefit from an annual follow-up including a collection of clinical data (age, sex, weight, comorbidities, swelling and painful joints), biological (CRP, ACPA, cross laps, lipids), radiological, BMO measures (Hologic), and treatments (biological and synthetic DMARDS). Each rheumatologic modification or stop of treatment is transcribed. Therapeutic maintenance definition: modification in rheumatologic treatment (number of DMARDS at 20 years)'}], 'secondaryOutcomes': [{'measure': 'evolution of lipidics parameters at 20 years of follow-up', 'timeFrame': '20 years', 'description': 'lipidics parameters ( total, HDL, LDL cholesterol and tryglicerides) are collected each years and modifications/evolution of these parameters will be studied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Disease', 'Rheumatoid Arthritis', 'Spondyloarthritis']}, 'descriptionModule': {'briefSummary': 'It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)', 'detailedDescription': 'All subjects were followed up on a yearly basis collection with clinical data (weight, sex, age, comorbidities, treatment), biological (VS, CRP, ACPA, lipid balance, cross laps), radiology (hand and foot radiographs and ultrasonography ), BMO Measure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients with a inflammatory disease (rheumatoid arthritis and spondyloarthritis) follow-up in the rheumatologic department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18 years\n* Rheumatoid arthritis meeting ACR criteria Spondyloarthritis meeting ASAS criteria\n\nExclusion Criteria:\n\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT03076866', 'acronym': 'PPCRNice', 'briefTitle': 'Prospective Follow-up of Patients With Chronic Inflammatory Rheumatism', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Suivi Prospectif Des Patients Presentant un Rhumatisme Inflammatoire Chronique', 'orgStudyIdInfo': {'id': '260'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational follow-up:clinical, radiological et biological', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'christian H ROUX, PhD', 'role': 'CONTACT', 'email': 'roux.c2@chu-nice.fr', 'phone': '492035512'}], 'facility': 'rheumatology department CHU nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'christian H roux, PhD', 'role': 'CONTACT', 'email': 'roux.c2@chu-nice.fr', 'phone': '492035512'}], 'overallOfficials': [{'name': 'christian roux, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Service de Rhumatologie', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Nice'}}}}