Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT06527534
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.
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.
Study:
NCT06527534
Study Brief:
Protocol Section:
NCT06527534