Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
- Registration Number
- NCT06527534
- Lead Sponsor
- Universita di Verona
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Filgotinib Filgotinib Filgotinib 200 mg qd Adalimumab Adalimumab Adalimumab 40 mg q2wk
- Primary Outcome Measures
Name Time Method micro RNA (miRNA) 12 weeks Fold increase in miRNA intensity measurements on the base-two logarithmic scale
- Secondary Outcome Measures
Name Time Method Proteomic profile 12 weeks Fold increase in proteins intensity measurements on the base-two logarithmic scale
American College of Rheumatology 20% Improvement (ACR20) 12 weeks Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
Physician's Global Assessment of Disease Activity (PGA) 12 weeks Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 12 (range 0 - 10, higher numbers are worse)
Health Assessment Questionnaire-Disability Index (HAQ-DI) 12 weeks Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 (range 0.000 - 3.000, higher numbers are worse)
Disease Activity Score 28 joints measured with CRP (DAS28-CRP) 12 weeks Change From Baseline in Disease Activity Score 28 joints measured with CRP (DAS28-CRP) at Weeks 12 (range 0.96 - 8.61, higher numbers are worse)
36-Item Short Form Survey (SF-36) 12 weeks Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 (range 0 - 100, lower numbers are worse)
Pain on Numeric Rating Scale (NRS) 12 weeks Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 12 (range 0 - 10, higher numbers are worse)
Clinical Disease Activity Index (CDAI) 12 weeks Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 12 (range 0 - 76, higher numbers are worse)
Functional Assessment of Chronic Illness Therapy (FACIT) 12 weeks Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 (range 0 - 52, lower numbers are worse)
American College of Rheumatology 50% Improvement (ACR50) 12 weeks Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12
Tender Joint Count 12 weeks Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12
Swollen Joint Count 12 weeks Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12
Subject's Global Assessment of Disease Activity (SGA) 12 weeks Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 12 (range 0 - 10, higher numbers are worse)
Simplified Disease Activity Index (SDAI) 12 weeks Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 12 (range 0 - 91, higher numbers are worse)
Trial Locations
- Locations (1)
Rheumatology Section, University of Verona
🇮🇹Verona, Italy