Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-03-06 @ 3:17 PM
Study NCT ID:
NCT06527534
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
Sponsor:
Universita di Verona
Organization:
Study Overview
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)
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FILRA
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: