Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
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)
Universita di Verona
30 participants
Jul 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria6
- 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)
Interventions
Patients will receive pills of Filgotinib 200 mg qd for 12 weeks
Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06527534