Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-24 @ 10:56 AM
Study NCT ID:
NCT06977035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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': 'D000092184', 'term': 'Nerve Conduction Studies'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-10', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-05-10', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of Peripheral Neuropathy in Rheumatoid Arthritis Patients on Baricitinib', 'timeFrame': '6 months', 'description': 'Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on Baricitinib in comparison to those on conventional synthetic DMARDs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '38240831', 'type': 'BACKGROUND', 'citation': 'Di Matteo A, Bathon JM, Emery P. Rheumatoid arthritis. Lancet. 2023 Nov 25;402(10416):2019-2033. doi: 10.1016/S0140-6736(23)01525-8. Epub 2023 Oct 27.'}, {'pmid': '9652497', 'type': 'BACKGROUND', 'citation': 'Grassi W, De Angelis R, Lamanna G, Cervini C. The clinical features of rheumatoid arthritis. Eur J Radiol. 1998 May;27 Suppl 1:S18-24. doi: 10.1016/s0720-048x(98)00038-2.'}, {'pmid': '29687421', 'type': 'BACKGROUND', 'citation': 'Al-Salama ZT, Scott LJ. Baricitinib: A Review in Rheumatoid Arthritis. Drugs. 2018 May;78(7):761-772. doi: 10.1007/s40265-018-0908-4.'}, {'pmid': '15961865', 'type': 'BACKGROUND', 'citation': 'Mallik A, Weir AI. Nerve conduction studies: essentials and pitfalls in practice. J Neurol Neurosurg Psychiatry. 2005 Jun;76 Suppl 2(Suppl 2):ii23-31. doi: 10.1136/jnnp.2005.069138. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis is a chronic, systemic, autoimmune inflammatory disease that mainly affects the joints and periarticular soft tissues. Baricitinib (Olumiant®) is an oral, targeted synthetic DMARD that inhibits JAK1 and JAK2, which are implicated in the pathogenesis of rheumatoid arthritis (RA). Nerve conduction studies (NCSs) are an essential tool in the evaluation of the peripheral nervous system. The sensory nerve action potential (SNAP) provides information on the sensory nerve axon and its pathway from the distal receptors in the skin to the dorsal root ganglia, while the compound muscle action potential (CMAP) is an assessment of the motor nerve fibers from their origins in the anterior horn cell to their termination along muscle fibers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients fulfill the 2010 ACR/EULAR classification criteria of RA\n2. Age above 18 years old.\n3. Patient cooperative and can answer questions\n\nExclusion Criteria:\n\n1. Other rheumatologic or collagen diseases.\n2. Age below 18 years and above 65 years.\n3. Uncooperative patients.\n4. Patients with other causes of peripheral neuropathy as Diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT06977035', 'briefTitle': 'Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib', 'orgStudyIdInfo': {'id': 'Soh--Med--25-4-09MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rheumatoid Arthritis patients on Baricitinib treatment', 'interventionNames': ['Device: Nerve Conduction Study']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rheumatoid Arthritis patient on conventional synthetic DMARD', 'interventionNames': ['Device: Nerve Conduction Study']}], 'interventions': [{'name': 'Nerve Conduction Study', 'type': 'DEVICE', 'description': 'Sensory and Motor Nerve Conduction study on upper and lower limbs.', 'armGroupLabels': ['Rheumatoid Arthritis patient on conventional synthetic DMARD', 'Rheumatoid Arthritis patients on Baricitinib treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sara K Mohamed, Resident', 'role': 'CONTACT', 'email': 'sara.khairy@med.sohag.edu.eg', 'phone': '01155791113'}, {'name': 'Ahmed R Alagamy, Associate Professor', 'role': 'CONTACT', 'email': 'ahmed_radwan@med.sohag.edu.eg', 'phone': '01092914019'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Physical medicine, Rheumatology and Rehabilitation Department, Sohag University Hospital', 'investigatorFullName': 'Sara Khairy Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}