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.
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
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)
Parallel
Filgotinib
DrugPatients will receive pills of Filgotinib 200 mg qd for 12 weeks
Adalimumab
DrugPatients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks
micro RNA (miRNA)
Fold increase in miRNA intensity measurements on the base-two logarithmic scale
Proteomic profile
Fold increase in proteins intensity measurements on the base-two logarithmic scale
American College of Rheumatology 20% Improvement (ACR20)
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 (range 0.000 - 3.000, higher numbers are worse)
Disease Activity Score 28 joints measured with CRP (DAS28-CRP)
Change From Baseline in Disease Activity Score 28 joints measured with CRP (DAS28-CRP) at Weeks 12 (range 0.96 - 8.61, higher numbers are worse)
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