Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-03-06 @ 3:17 PM
Study NCT ID:
NCT06527534
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
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': 'C584571', 'term': 'GLPG0634'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'micro RNA (miRNA)', 'timeFrame': '12 weeks', 'description': 'Fold increase in miRNA intensity measurements on the base-two logarithmic scale'}], 'secondaryOutcomes': [{'measure': 'Proteomic profile', 'timeFrame': '12 weeks', 'description': 'Fold increase in proteins intensity measurements on the base-two logarithmic scale'}, {'measure': 'American College of Rheumatology 20% Improvement (ACR20)', 'timeFrame': '12 weeks', 'description': 'Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12'}, {'measure': 'Health Assessment Questionnaire-Disability Index (HAQ-DI)', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 (range 0.000 - 3.000, higher numbers are worse)'}, {'measure': 'Disease Activity Score 28 joints measured with CRP (DAS28-CRP)', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in Disease Activity Score 28 joints measured with CRP (DAS28-CRP) at Weeks 12 (range 0.96 - 8.61, higher numbers are worse)'}, {'measure': '36-Item Short Form Survey (SF-36)', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 (range 0 - 100, lower numbers are worse)'}, {'measure': 'Functional Assessment of Chronic Illness Therapy (FACIT)', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 (range 0 - 52, lower numbers are worse)'}, {'measure': 'American College of Rheumatology 50% Improvement (ACR50)', 'timeFrame': '12 weeks', 'description': 'Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12'}, {'measure': 'Tender Joint Count', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12'}, {'measure': 'Swollen Joint Count', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12'}, {'measure': "Subject's Global Assessment of Disease Activity (SGA)", 'timeFrame': '12 weeks', 'description': "Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 12 (range 0 - 10, higher numbers are worse)"}, {'measure': "Physician's Global Assessment of Disease Activity (PGA)", 'timeFrame': '12 weeks', 'description': "Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 12 (range 0 - 10, higher numbers are worse)"}, {'measure': 'Pain on Numeric Rating Scale (NRS)', 'timeFrame': '12 weeks', 'description': "Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 12 (range 0 - 10, higher numbers are worse)"}, {'measure': 'Clinical Disease Activity Index (CDAI)', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 12 (range 0 - 76, higher numbers are worse)'}, {'measure': 'Simplified Disease Activity Index (SDAI)', 'timeFrame': '12 weeks', 'description': 'Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 12 (range 0 - 91, higher numbers are worse)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RA'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nThe study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients.\n\nStudy Design:\n\nThis is a single-center, prospective randomized study.', 'detailedDescription': 'Population:\n\nThe study will include 30 patients with active rheumatoid arthritis: 15 patients treated with Filgotinib. 15 patients treated with Adalimumab (used as a comparison group).\n\nProcedures:\n\nParticipants will have blood samples taken at the start and then every 4 weeks up to 12 weeks. These samples will be used to analyze changes in proteins and micro-RNA. Participants will continue their regular rheumatoid arthritis treatment during the study.\n\nPrimary Objective:\n\nTo observe changes in the metabolic profile (proteins and micro-RNA) in patients treated with Filgotinib.\n\nSecondary Objectives:\n\nCompare the metabolic profile changes between Filgotinib and Adalimumab. Identify metabolic factors associated with early clinical response to Filgotinib.\n\nSafety and Data Management:\n\nAdverse events will be monitored and reported. Patient confidentiality will be maintained according to privacy laws.\n\nStudy Duration:\n\nRecruitment: 16 weeks. Patient involvement: 12 weeks. Total study duration: 28 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria with active disease (Disease Activity Score 28-joints C-reactive protein \\[DAS28 CRP\\] \\>5.1 and/or Clinical Disease Activity Index \\[CDAI\\] \\>22)\n* Age \\> 18, \\<65 years\n* Patients for whom treatment with filgotinib or adalimumab might be planned\n\nExclusion criteria\n\n* History of major cardiovascular events or stroke\n* History of venous thromboembolism\n* Active smokers or past smokers \\>10 pack/years\n* History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5)\n* Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab)\n* Chronic treatment with moderate to high dose of glucocorticoids (≥7.5 mg/day of prednisone equivalent for more than 3 months prior to enrollment), short term (\\<3 months) will be accepted if tapered, as clinically feasible, to \\<7.5 mg/day before enrollment)'}, 'identificationModule': {'nctId': 'NCT06527534', 'acronym': 'FILRA', 'briefTitle': 'Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)', 'organization': {'class': 'OTHER', 'fullName': 'Universita di Verona'}, 'officialTitle': 'Exploring the Effects of Filgotinib, an Oral JAK-1 Selective Inhibitor, Proteomic Profile and Micro-RNA Expression in Peripheral Blood Mononuclear Cell (PBMC) of Patients With Active Rheumatoid Arthritis (RA)', 'orgStudyIdInfo': {'id': '215CET - FILRA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Filgotinib', 'description': 'Filgotinib 200 mg qd', 'interventionNames': ['Drug: Filgotinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adalimumab', 'description': 'Adalimumab 40 mg q2wk', 'interventionNames': ['Drug: Adalimumab']}], 'interventions': [{'name': 'Filgotinib', 'type': 'DRUG', 'description': 'Patients will receive pills of Filgotinib 200 mg qd for 12 weeks', 'armGroupLabels': ['Filgotinib']}, {'name': 'Adalimumab', 'type': 'DRUG', 'description': 'Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks', 'armGroupLabels': ['Adalimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37100', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Adami, MD', 'role': 'CONTACT', 'email': 'giovanni.adami@univr.it', 'phone': '+390458122574'}], 'facility': 'Rheumatology Section, University of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Giovanni Adami, MD', 'role': 'CONTACT', 'email': 'giovanni.adami@univr.it', 'phone': '+390458122574'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita di Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giovanni Adami', 'investigatorAffiliation': 'Universita di Verona'}}}}