Status:
RECRUITING
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
Lead Sponsor:
Universita di Verona
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Detailed Description
Population: 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: P...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06527534
Start Date
July 15 2024
End Date
September 15 2025
Last Update
August 1 2024
Active Locations (1)
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1
Rheumatology Section, University of Verona
Verona, Italy, 37100