Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-03-02 @ 2:12 AM
Study NCT ID:
NCT02410304
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2015-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013585', 'term': 'Synovitis'}], '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': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 561}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.', 'timeFrame': '1 year', 'description': 'The primary outcome is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of rheumatoid arthritis patients (ACR/EULAR 2010) according to remission defined by modified SDAI in order to evaluate in all cases the same number of joints \\[Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and practitioner with VAS, and PCR ≤ 3.3mg/l\\] (mode C), with a combined approach clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B) or an ultrasound approach (remission défined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the proportion of rheumatoid arthristis in remission according to the method used', 'timeFrame': 'at 3 month, 6 month, 9 month and 1 year'}, {'measure': 'Assessement of the Xrays evolution at 2 years', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis / ultrasonography / synovitis'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D) concerning the rheumatoid arthritis in order to monitore the treatment. This study will provide the exact number of patients in remission according the 3 methods.\n\nIt could allow to assess the concordance between the 3 evaluated methods. This study will permit to define the best method which limit the evolution of structural damages ( principal criteria).', 'detailedDescription': 'The aim of this study is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of patients affected by rheumatoid arthritis (ACR/EULAR 2010). The first approach is the assessment of remission defined by modified SDAI in order to evaluate in all cases the same number of joints \\[Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and and practitioner with VAS, and PCR ≤ 3.3mg/l\\] (mode C). The second one is a combined approach: clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B). The last one is an ultrasound approach (remission defined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).\n\nThis trial is a National randomized multicentre trial that compares three modes of follow to adjust the therapeutic adaptation in Rheumatoid Artritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * Both gender patients aged 18 -to 80 years old\n * Patients will be eligible if they fulfill ACR/EULAR 2010 rheumatoid arthritis\n * All the treatment recommended for rheumatoïd arthritis (anti-inflammatory drugs, steroids, hydroxychloroquine, salazopyrine, methotrexate, ARAVA or biologics treatment: Enbrel, humira, remicade, cimzia, tocilizumab, rituximab, abatacept, simponi) would be in stable posology since at least 12 weeks before inclusion\n * Patients would be able to understand and be agree with the protocole\n * Patients would be able to consent\n* Exclusion Criteria:\n\n * Patient unable to cooperate patient and who refuse to sign consent form\n * Patient unable to understand the study,under administrative supervision or legal guardianship\n * Signs and symptoms of uncontroled or severe progressive pathology at the level of renal, hepatic, hematological, endocrine, lung, cardiac, neurological or cerebral\n * Scheduled surgery procedure during the study on the estimated joint.\n * Patient non-affiliated to social security\n * Pregnant and nursing mothers'}, 'identificationModule': {'nctId': 'NCT02410304', 'acronym': 'BCD', 'briefTitle': 'Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment', 'orgStudyIdInfo': {'id': 'BCD 29BRC14.0097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm C (Clinical)', 'description': 'No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation.', 'interventionNames': ['Device: Xrays']}, {'type': 'OTHER', 'label': 'Arm B (Clinical + Ultrasound)', 'description': 'No drug and no placebo were used in this arm. Patients were followed by Clinical evaluation in combination with ultrasound (in B mode).', 'interventionNames': ['Device: Xrays', 'Device: Ultrasound (B mode )']}, {'type': 'OTHER', 'label': 'Arm D (Ultrasound)', 'description': 'No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode.', 'interventionNames': ['Device: Ultrasound (D mode)']}], 'interventions': [{'name': 'Xrays', 'type': 'DEVICE', 'description': 'Clinical evaluation', 'armGroupLabels': ['Arm B (Clinical + Ultrasound)', 'Arm C (Clinical)']}, {'name': 'Ultrasound (B mode )', 'type': 'DEVICE', 'armGroupLabels': ['Arm B (Clinical + Ultrasound)']}, {'name': 'Ultrasound (D mode)', 'type': 'DEVICE', 'armGroupLabels': ['Arm D (Ultrasound)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHU La Roche sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '72037', 'city': 'Le Mans', 'country': 'France', 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '56322', 'city': 'Lorient', 'country': 'France', 'facility': 'CH de Lorient', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': 'CHR Orléans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '35203', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU SUD Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '56017', 'city': 'Vannes', 'country': 'France', 'facility': 'CH Vannes', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}