Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)

NCT06527534 · Universita di Verona

Recruiting

In plain English

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Official title

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)

About this study

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: Participants will have blood samples taken at the start and then every 4 weeks up to 12 weeks. These samples will be used to analyze changes in proteins and micro-RNA. Participants will continue their regular rheumatoid arthritis treatment during the study. Primary Objective: To observe changes in the metabolic profile (proteins and micro-RNA) in patients treated with Filgotinib. Secondary Objectives: Compare the metabolic profile changes between Filgotinib and Adalimumab. Identify metabolic factors associated with early clinical response to Filgotinib. Safety and Data Management: Adverse events will be monitored and reported. Patient confidentiality will be maintained according to privacy laws. Study Duration: Recruitment: 16 weeks. Patient involvement: 12 weeks. Total study duration: 28 weeks.

Eligibility criteria

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)

Study design

Enrollment target: 30 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2024-07-15

Estimated completion: 2025-09-15

Last updated: 2024-08-01

Interventions

Drug: FilgotinibDrug: Adalimumab

Primary outcomes

• micro RNA (miRNA) (12 weeks)

Sponsor

Universita di Verona · other

Contacts & investigators

ContactGiovanni Adami, MD · contact · giovanni.adami@univr.it · +390458122574

All locations (1)

Rheumatology Section, University of VeronaRecruiting

Verona, Italy

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