Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT06558305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-16
First Post:
2024-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IL-6, IL-12, IL-15 and IL-23 Expression Levels in Rheumatoid Arthritis Patients
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': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the effect of cDMARD and Baricitinib (JAKi) therapy on gene expressions of IL-6, IL-12, IL-15 and, IL-23 in patients with RA relative to the healthy controls.', 'timeFrame': '6 months', 'description': 'assess the effect of cDMARD and Baricitinib (JAKi) therapy on gene expressions of IL-6, IL-12, IL-15 and, IL-23 in patients with RA relative to the healthy controls.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Rheumatoid Arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and articular damage.\n\nContinuous medical research has dramatically improved the outcomes for patients with RA. Traditional therapeutic approaches have relied on glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) and disease modifying antirheumatic drugs (DMARDs) such as methotrexate, sulfasalazine or leflunomide. Glucocorticoids and NSAIDs interfere with the inflammatory cascades while DMARDs impede both the inflammatory and the destructive processes of RA.\n\nThese drugs, although efficient, are not specifically directed against inflammatory cells or cytokines and are associated with significant toxicity. The development of biologic DMARDs (bDMARDs), has been an important step forward. Their ability to neutralize specific cytokines or target distinct immune cells filled a gap in existing treatment options for RA. \\[3\\]. However, some patients still have only partial or no response to bDMARDs. More recently, a group of drugs has been developed that inhibit the janus kinase (JAK) family of intracellular tyrosine kinases, which transmit cytokine- mediated signals via the JAK-signal transducer and activator of transcription (STAT) pathway \\[4\\]. Baricitinib, with a selectivity to inhibit JAK1 and 2, has been FDA approved for RA in 2018 \\[5\\].\n\nMany cytokines such IL-6, IL-12, IL-15, IL-23, (GM-CSF) and (IFNs) are associated with the pathogenesis of RA. These cytokines transduce signals via the JAK-STAT pathway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'this study will include 30 RA patients receiving cDMARDs, 30 RA patients receiving baricitinib and 20 healthy participants.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age is at leasr18 years old,\n* established RA diagnosis according to 2010 the American College of Rheumatology/European League against Rheumatism classification criteria\n\nExclusion Criteria:\n\n* Associated autoimmune diseases,\n* connective tissue diseases,\n* chronic liver or kidney diseases or\n* genetic diseases'}, 'identificationModule': {'nctId': 'NCT06558305', 'briefTitle': 'IL-6, IL-12, IL-15 and IL-23 Expression Levels in Rheumatoid Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of cDMARD and Baricitinib Therapy on IL-6, IL-12, IL-15 and IL-23 Expression Levels in Rheumatoid Arthritis Patients', 'orgStudyIdInfo': {'id': 'Interleukins in RA patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients on cDMARDS', 'interventionNames': ['Other: blood sample']}, {'label': 'Patients on janus kinase (JAK) inhibitors', 'interventionNames': ['Other: blood sample']}, {'label': 'Control', 'interventionNames': ['Other: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'description': "Total RNA will be extracted from the whole blood using a commercial extraction kit (RNA Extraction Kit, applied biotechnology Co.Ltd, Egypt) according to the manufacturer's instructions. RNA will be stored at -80°C.The extracted RNA will be used for cDNA synthesis using commercial kits (cDNA Synthesis Kit, applied biotechnology Co.Ltd, Egypt), according to the manufacturer's instruction.", 'armGroupLabels': ['Control', 'Patients on cDMARDS', 'Patients on janus kinase (JAK) inhibitors']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Maha Sayed Ibrahim Abdelrahman', 'investigatorAffiliation': 'Assiut University'}}}}