Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 9:55 AM
Study NCT ID:
NCT05683769
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2023-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
microRNA in Erosive Hand Osteoarthritis and Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035683', 'term': 'MicroRNAs'}], 'ancestors': [{'id': 'D016372', 'term': 'RNA, Antisense'}, {'id': 'D016375', 'term': 'Antisense Elements (Genetics)'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012313', 'term': 'RNA'}, {'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D058727', 'term': 'RNA, Small Untranslated'}, {'id': 'D022661', 'term': 'RNA, Untranslated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MicroRNA expression profile', 'timeFrame': 'Baseline', 'description': 'miR-21, miR-140, miR-146a, miR-155, miR-181a, miR-223, miR-23a, miR-26a and miR-let-7e expression in peripheral blood mononuclear cells'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erosive Osteoarthritis', 'Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'Erosive osteoarthritis of the hand (EHOA) is a rare subset of HOA that affects mainly postmenopausal middle-aged women, featured by prominent signs of inflammation, severe progression, and typical radiographic changes of the interphalangeal (IP). It is presently debated whether EHOA is an advanced stage of the classical HOA or a separate entity with peculiar inflammatory features, which can mimic chronic arthritis such as psoriatic arthritis (PsA). PsA is a chronic immune-mediated inflammatory arthropathy, that affects 14.0-22.7% of patients with psoriasis. It is a highly heterogeneous disease, whose clinical features often vary from peripheral arthritis, to spinal spondylitis, and/or asymmetrical synovitis, enthesitis, dactylitis. As no gold-standard diagnostic test for PsA exists, the diagnosis is based on different patterns of clinical, radiological and serological markers included in the classification criteria for psoriatic arthritis (CASPAR). Some typical features of PsA are also observed in other chronic musculoskeletal diseases, as rheumatoid arthritis (RA) and HOA, determining possible delay of the diagnosis and consequent influence on the successful results of the therapies. In particular, the differential diagnosis of PsA and EHOA is very challenging, considering that both conditions can be characterized by bone proliferation and inflammation processes in the distal IP joints and lack of specific diagnostic biomarkers.\n\nIn the last decade, microRNA (miRNA) are emerged as possible candidate biomarkers in different rheumatic diseases. They are a class of small non-coding RNA molecules implicated in the direct regulation of the expression of different target genes by repressing or inhibiting translation. Mature miRNA are produced inside the cell and exert their function in the cytoplasm, but also by being released into the circulation and body fluids, where they regulate both physiological and pathological processes. Specific profiles of miRNA have been associated with the up-regulation of several inflammatory cytokines or degrading enzymes involved in the pathogenesis of PsA or OA. Indeed, miRNA have been detected in human plasma and in synovial fluid from patients with PsA and are considered possible diagnostic and prognostic biomarkers of this disease; very recently a pattern of circulating miRNAs has been studied also in patients with HOA.\n\nIThe aim of the present study is to test whether miRNA can help to differentiate EHOA from PsA. In detail, the investigators evaluate the expression profile of a series of miRNA (miR-21, miR-140, miR-146a, miR-155, miR-181a, miR-223, miR-23a, miR-26a and miR-let-7e), known to be dysregulated in PsA and OA, in peripheral blood mononuclear cells (PBMCs) of patients with EHOA and PsA and in comparison to a group of healthy controls (HC).\n\nFurthermore, the investigators assess the potential correlation between miRNA expression and disease activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population included patients with erosive hand osteoarthritis, patients with psoriatic arthritis and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor EHOA group:\n\n* Diagnosis of EHOA according to the American College of Rheumatology (ACR) criteria and to the presence of the classical central erosion in at least two IP joints.\n* Availability of plain radiography of both hands performed in the previous 6 months. Plain radiographs of both hands were collected and scored by two readers according to Kallman's classificationin a blind observation.\n\nFor PsA group:\n\n* Diagnosis of PsA following the CASPAR classification guidelines\n* peripheral arthritis pattern\n* concomitant diagnosis of psoriasis confirmed by an expert dermatologist\n* Naive to conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) or have withdrawn any DMARDs for at least three months, because of inadequate response or intolerance.\n\nFor control group:\n\n* Healthy volunteers age-and sex-matched to study patients recruited among the hospital staff\n* no symptoms or signs attributable to OA, psoriasis, as well as to autoimmune disorders and systemic inflammatory arthropathies.\n\nExclusion Criteria:\n\nFor all subjects:\n\n* other rheumatic and not rheumatic diseases which can affect the functionality of the peripheral joints, as tendinopathies, carpal tunnel syndrome, Dupuytren's contractures, collagen diseases, neurological disorders or arthroplasty of the upper and lower limbs, recent trauma, or surgery of the concerned joints\n* presence of inflammatory bowel diseases, liver or kidney diseases, acute or chronic infectious disorders, malignancy in the previous 5 years, pregnancy and breastfeeding.\n* treatment with systemic or intra-articular (i.a.) corticosteroids, or with i.a. hyaluronic acid during the last three months.\n* treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months\n\nFor EHOA group:\n\n\\- therapy with Symptomatic Slow Acting Drugs for Osteoarthritis (SYSADOAs) during the previous 6 months.\n\nFor PsA group:\n\n\\- PsA with pure axial involvement on the basis of inflammatory spinal pain and/or sacroiliac syndrome with spinal or sacroiliac radiographic changes and mixed involvement."}, 'identificationModule': {'nctId': 'NCT05683769', 'briefTitle': 'microRNA in Erosive Hand Osteoarthritis and Psoriatic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Can microRNA Help to Differentiate Erosive Hand Osteoarthritis From Psoriatic Arthritis?', 'orgStudyIdInfo': {'id': 'miRNA EHOA vs PsA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'erosive hand osteoarthritis', 'description': "EHOA was diagnosed according to the American College of Rheumatology (ACR) criteria and to the presence of the classical central erosion in at least two IP joints. Further inclusion criteria were the availability of plain radiography of both hands performed in the previous 6 months. Plain radiographs of both hands were collected and scored by two readers according to Kallman's classification in a blind observation.", 'interventionNames': ['Genetic: miRNA']}, {'label': 'psoriatic arthritis', 'description': 'PsA was diagnosed following the CASPAR classification guidelines and only patients with the peripheral arthritis pattern were considered; all PsA group had also the diagnosis of psoriasis confirmed by an expert dermatologist. These patients had also to be naive to conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) or have withdrawn any DMARDs for at least three months, because of inadequate response or intolerance.', 'interventionNames': ['Genetic: miRNA']}, {'label': 'Control Group', 'description': 'The control group was represented by healthy volunteers age-and sex-matched to study patients and were recruited among the hospital staff; HC did not exhibit symptoms or signs attributable to OA, psoriasis, as well as to autoimmune disorders and systemic inflammatory arthropathies.', 'interventionNames': ['Genetic: miRNA']}], 'interventions': [{'name': 'miRNA', 'type': 'GENETIC', 'description': 'Assessment of miRNA, as potential biomarkers to discriminate erosive hand osteoarthritis from psoriatic arthritis', 'armGroupLabels': ['Control Group', 'erosive hand osteoarthritis', 'psoriatic arthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Rheumatology Unit Azienda Ospedaliera Universitaria Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'fioravanti antonella', 'investigatorAffiliation': 'University of Siena'}}}}