Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-28 @ 6:28 PM
Study NCT ID:
NCT02813720
Status:
UNKNOWN
Last Update Posted:
2016-06-28
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distal Erosions and Nail Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D054039', 'term': 'Onycholysis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009260', 'term': 'Nail Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine Serum and plasma Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'distal phalangeal bone erosion of the 2 index fingers of the hand', 'timeFrame': 'at baseline and after 4 years of follow-up', 'description': 'assessment by HR-pQCT'}], 'secondaryOutcomes': [{'measure': 'enthesopathy of the 2 index fingers of the hand', 'timeFrame': 'at baseline and after 4 years of follow-up', 'description': 'assessment by ultrasonography'}, {'measure': 'Rheumatoid factors', 'timeFrame': 'Biomarkers are assessed at baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erosions', 'Onycholysis', 'HR-pQCT', 'Psoriatic arthritis'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '32885241', 'type': 'DERIVED', 'citation': 'Villani AP, Boutroy S, Coutisson C, Carlier MC, Barets L, Marotte H, Richert B, Chapurlat RD, Jullien D, Confavreux CB. Distal phalangeal bone erosions observed by HR-pQCT in patients with psoriatic onycholysis. Rheumatology (Oxford). 2021 Mar 2;60(3):1176-1184. doi: 10.1093/rheumatology/keaa415.'}]}, 'descriptionModule': {'briefSummary': 'Nearly 30% of patients with cutaneous psoriasis (PsO) developed psoriatic arthritis (PsA). Among these patients 20 % will have severe destructive arthritis. The risk of developing PsA is significantly higher in patients with nail involvement (OR = 2.24; 95% CI \\[1.26-3.98\\]). The risk is particularly high for the peripheral form of PsA and onycholysis (OR=2.80; 95% CI \\[1.34-5.85\\]).\n\nThus the investigators wanted to test the hypothesis that onycholysis, in patients without PsA, is a potential clinical marker of subclinical distal enthesopathy and, by extension, of bone micro-structural alterations.\n\nPatients and Methods\n\nThe investigators will recruit 4 groups of subjects:\n\n1. Patients with peripheral PsA,\n2. Patients with psoriatic nail onycholysis,\n3. Patients with PsO only\n4. Healthy match control subjects. The investigators will assess the presence of enthesopathy by ultrasonography and bone structural damages (by HR-pQCT) in all subjects at baseline and 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PSUPSO is a prospective study. Diagnosis of PsA is based on the CASPAR criteria (Taylor 2006). PASI, NAPSI and NAPSI target are recorded. PsO patients are gender and age matched with onycholysis patients patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults over 18 years and until 65 years\n* both gender\n* covered by the French National Insurance\n* subjects entering one of the 4 groups.\n\nExclusion Criteria:\n\n* Treatment by biological agents are an exclusion criteria for PsO, onycholysis and control patients.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02813720', 'acronym': 'PSUPSO', 'briefTitle': 'Distal Erosions and Nail Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis', 'orgStudyIdInfo': {'id': '69HCL16_0202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with peripheral PsA', 'interventionNames': ['Radiation: HR-pQCT High resolution peripheral quantitative CT-scan']}, {'label': 'Patients with psoriatic nail onycholysis', 'interventionNames': ['Radiation: HR-pQCT High resolution peripheral quantitative CT-scan']}, {'label': 'Patients with PsO only', 'interventionNames': ['Radiation: HR-pQCT High resolution peripheral quantitative CT-scan']}, {'label': 'Healthy match control subjects', 'interventionNames': ['Radiation: HR-pQCT High resolution peripheral quantitative CT-scan']}], 'interventions': [{'name': 'HR-pQCT High resolution peripheral quantitative CT-scan', 'type': 'RADIATION', 'description': 'HR-pQCT is a powerful device providing low dose irradiation already used in bone field.\n\nIt is a high resolution tool (voxel size=82µm) that the investigators adapted to look after the distal joint involved by onycholysis. An anteroposterior scout view is used to define the region of interest (ROI), which spanned from the top of the distal phalange to the distal part of the intermediate phalange in order to contain the distal joint of the target finger. Images are then analysed for erosions, osteophytes and volumetric bone mineral density.', 'armGroupLabels': ['Healthy match control subjects', 'Patients with PsO only', 'Patients with peripheral PsA', 'Patients with psoriatic nail onycholysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cyrille Confavreux, MD PHD', 'role': 'CONTACT', 'email': 'cyrille.confavreux@chu-lyon.fr', 'phone': '(0)4 72 11 74 79', 'phoneExt': '+33'}, {'name': 'Céline Coutisson, clinical research assistant', 'role': 'CONTACT', 'email': 'centre.prevention@wanadoo.fr', 'phone': '(0)4 72 11 74 46', 'phoneExt': '+33'}], 'facility': "Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Cyrille Confavreux, MD PHD', 'role': 'CONTACT', 'email': 'cyrille.confavreux@chu-lyon.fr', 'phone': '(0)4 72 11 74 79', 'phoneExt': '+33'}, {'name': 'Céline Coutisson, clinical research assistant', 'role': 'CONTACT', 'email': 'centre.prevention@wanadoo.fr', 'phone': '(0)4 72 11 74 46', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Cyrille Confavreux, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}