Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527534
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis RA
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None