Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
NCT ID: NCT06527534
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2024-07-15
2025-09-15
Brief Summary
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The 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.
Study Design:
This is a single-center, prospective randomized study.
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Detailed Description
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The study will include 30 patients with active rheumatoid arthritis: 15 patients treated with Filgotinib. 15 patients treated with Adalimumab (used as a comparison group).
Procedures:
Participants 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.
Primary Objective:
To observe changes in the metabolic profile (proteins and micro-RNA) in patients treated with Filgotinib.
Secondary Objectives:
Compare the metabolic profile changes between Filgotinib and Adalimumab. Identify metabolic factors associated with early clinical response to Filgotinib.
Safety and Data Management:
Adverse events will be monitored and reported. Patient confidentiality will be maintained according to privacy laws.
Study Duration:
Recruitment: 16 weeks. Patient involvement: 12 weeks. Total study duration: 28 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Filgotinib
Filgotinib 200 mg qd
Filgotinib
Patients will receive pills of Filgotinib 200 mg qd for 12 weeks
Adalimumab
Adalimumab 40 mg q2wk
Adalimumab
Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks
Interventions
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Filgotinib
Patients will receive pills of Filgotinib 200 mg qd for 12 weeks
Adalimumab
Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Age \> 18, \<65 years
* Patients for whom treatment with filgotinib or adalimumab might be planned
Exclusion Criteria
* History of venous thromboembolism
* Active smokers or past smokers \>10 pack/years
* History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5)
* Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab)
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Universita di Verona
OTHER
Responsible Party
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Giovanni Adami
Principal Investigator
Locations
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Rheumatology Section, University of Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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215CET - FILRA
Identifier Type: -
Identifier Source: org_study_id
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