Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoi… (NCT06527534) | Clinical Trial Compass
RecruitingPhase 4
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
Italy30 participantsStarted 2024-07-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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)