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Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
RECRUITINGPhase 4Sponsored by Universita di Verona
Actively Recruiting
PhasePhase 4
SponsorUniversita di Verona
Started2024-07-15
Est. completion2025-07-15
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06527534
Summary
Purpose: 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.
Eligibility
Age: 18 Years – 65 YearsHealthy volunteers accepted
Inclusion criteria * 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) * Age \> 18, \<65 years * Patients for whom treatment with filgotinib or adalimumab might be planned Exclusion criteria * History of major cardiovascular events or stroke * 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)
Conditions2
ArthritisRheumatoid Arthritis
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Actively Recruiting
PhasePhase 4
SponsorUniversita di Verona
Started2024-07-15
Est. completion2025-07-15
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06527534