Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-04-23 @ 2:01 PM
Study NCT ID:
NCT03004651
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMI and Ultrasound/Clinical Assessments of RA Disease Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-22', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the level of agreement between the number of abnormal joints and clinical evaluation', 'timeFrame': '18 months', 'description': 'Comparison of the level of agreement between the number of abnormal joints as defined by Power Doppler ultrasound (≥ grade 1 synovitis on a semi-quantitative scale) and clinical evaluation (swollen joint count (SJC) as componant of SDAI) in obese'}], 'secondaryOutcomes': [{'measure': "Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight", 'timeFrame': '18 months', 'description': 'Comparison of the level of agreement between clinical and ultrasound findings in overweighted versus normally weighted patients, when joint count evaluation is based on another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints, and based on a joint by joint evaluation'}, {'measure': 'Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam', 'timeFrame': '18 months', 'description': 'Evaluation of the impact of other factors than BMI on the level of agreement between Power Doppler ultrasound defined number of synovitis and clinically defined swollen joint count'}, {'measure': 'Reproducibility of the comparison between Ultrasound and clinical examination', 'timeFrame': '18 months', 'description': 'Reliability between Ultrasound and clinical examination across the different investigation centers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obsessional Erotomania']}, 'descriptionModule': {'briefSummary': 'Comparison of the level of agreement between Power Doppler ultrasound measured number of synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen joints in obese (i.e. BMI\\>30) versus normally weighted RA patients.', 'detailedDescription': 'Clinical evaluation of synovitis in rheumatoid arthritis (RA) is difficult in obese and overweighted patients, due to the fat pad located around the joint, that can over- or under estimate the number of joints regarded as swollen by clinical examination. RA in obese and overweighted patients has several distinctive characteristics as compared to the disease observed in normally weighted subjects: diease activity (assessed by composites scores such as Disease Activity Score (DAS28) or Simple Disease Activity Index (SDAI)) is higher, while response to treatment and severity (asessed by radiographic progression) are lower.\n\nObjectives:\n\nPrimary end point: Comparison of the level of agreement between the number of joints considered abnormal by Power Doppler ultrasound synovitis (≥ grade 1 on a semi-quantitative scale) and clinical examination (swollen joint count (SJC) as componant of SDAI) in obese (i.e. BMI\\>30) versus normally weighted RA patients.\n\nSecondary end points :\n\n* Comparison of the level of agreement between clinical and ultrasound findings in overweighted versus normally weighted patients, when joint count evaluation is based on another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints, and based on a joint by joint evaluation\n* Comparison of agreement between obese and non obese\n* Evaluation of the impact of other factors than BMI on the level of agreement between Power Doppler ultrasound defined number of synovitis and clinically defined swollen joint count\n* Reliability between Ultrasound and clinical examination across the different investigation centers Study design: prospective multicenter observational study Inclusion criteria: RA patients fulfilling ACR/EULAR 2010 criteria Exclusion criteria: patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients Outcome measure : Level of agreement between SJC and power Doppler US synovitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical evaluation of synovitis in rheumatoid arthritis (RA) is difficult in obese and overweighted patients, due to the fat pad located around the joint, that can over- or under estimate the number of joints regarded as swollen by clinical examination.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* RA patients fulfilling ACR/EULAR 2010 criteria\n\nExclusion criteria:\n\n* Patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients, pregnancy.'}, 'identificationModule': {'nctId': 'NCT03004651', 'acronym': 'RABODI', 'briefTitle': 'BMI and Ultrasound/Clinical Assessments of RA Disease Activity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Impact of Body Mass Index on the Agreement Between Ultrasound- and Clinical Assessments of Disease Activity in RA : Cross-sectionnal Study', 'orgStudyIdInfo': {'id': '9742'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese Patients', 'description': 'Power Doppler ultrasound on obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)', 'interventionNames': ['Other: Power Doppler ultrasound', 'Other: Clinical evaluation']}, {'label': 'Non obese patients', 'description': 'Power Doppler ultrasound on non obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)', 'interventionNames': ['Other: Power Doppler ultrasound', 'Other: Clinical evaluation']}], 'interventions': [{'name': 'Power Doppler ultrasound', 'type': 'OTHER', 'description': 'Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)', 'armGroupLabels': ['Non obese patients', 'Obese Patients']}, {'name': 'Clinical evaluation', 'type': 'OTHER', 'description': 'swollen joint count (SJC) as componant of SDAI', 'armGroupLabels': ['Non obese patients', 'Obese Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Languedoc-Roussillon', 'country': 'France', 'facility': 'University Regional Hospital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Gaël MOUTERDE, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pitié-Salpêtrière Hospital', 'class': 'OTHER'}, {'name': 'Hospital Ambroise Paré Paris', 'class': 'OTHER'}, {'name': 'Nantes University Hospital', 'class': 'OTHER'}, {'name': 'Rennes University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, {'name': 'CHU Brest Hôpital La Cavale Blanche', 'class': 'UNKNOWN'}, {'name': 'Hospital Purpan', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Lyon Sud', 'class': 'OTHER'}, {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de la côte Basque', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}