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

University of Verona

Status and phase: Enrolling; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Filgotinib; Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06527534

215CET - FILRA

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Filgotinib

Experimental group

Description:

Filgotinib 200 mg qd

Treatment:

Drug: Filgotinib

Adalimumab

Active Comparator group

Description:

Adalimumab 40 mg q2wk

Treatment:

Drug: Adalimumab