Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
NCT Number: NCT06527534
Acronym: FILRA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Rheumatoid Arthritis
Interventions: DRUG: Filgotinib|DRUG: Adalimumab
Sponsor: Universita di Verona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-09-15
Locations: Rheumatology Section, University of Verona, Verona, 37100, Italy

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.

Primary Outcome Measures: micro RNA (miRNA), Fold increase in miRNA intensity measurements on the base-two logarithmic scale, 12 weeks
Secondary Outcome Measures: Proteomic profile, Fold increase in proteins intensity measurements on the base-two logarithmic scale, 12 weeks|American College of Rheumatology 20% Improvement (ACR20), Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12, 12 weeks|Health Assessment Questionnaire-Disability Index (HAQ-DI), 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), 12 weeks|Disease Activity Score 28 joints measured with CRP (DAS28-CRP), 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), 12 weeks|36-Item Short Form Survey (SF-36), 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), 12 weeks|Functional Assessment of Chronic Illness Therapy (FACIT), Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 (range 0 - 52, lower numbers are worse), 12 weeks|American College of Rheumatology 50% Improvement (ACR50), Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12, 12 weeks|Tender Joint Count, Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12, 12 weeks|Swollen Joint Count, Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12, 12 weeks|Subject's Global Assessment of Disease Activity (SGA), 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), 12 weeks|Physician's Global Assessment of Disease Activity (PGA), 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), 12 weeks|Pain on Numeric Rating Scale (NRS), Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 12 (range 0 - 10, higher numbers are worse), 12 weeks|Clinical Disease Activity Index (CDAI), Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 12 (range 0 - 76, higher numbers are worse), 12 weeks|Simplified Disease Activity Index (SDAI), Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 12 (range 0 - 91, higher numbers are worse), 12 weeks