NCT06527534

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

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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: 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Filgotinib	Patients will receive pills of Filgotinib 200 mg qd for 12 weeks
DRUG	Adalimumab	Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-07-15
• Completion: 2025-09-15
• First posted: 2024-07-30
• Last updated: 2024-08-01

Locations

1 site across 1 country: Italy