Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)

Phase 4RecruitingNCT06527534

Universita di Verona30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

FilgotinibDRUG

Patients will receive pills of Filgotinib 200 mg qd for 12 weeks

AdalimumabDRUG

Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria * Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria with active disease (Disease Activity Score 28-joints C-reactive protein \[DAS28 CRP\] \>5.1 and/or Clinical Disease Activity Index \[CDAI\] \>22) * Age \> 18, \<65 years * Patients for whom treatment with filgotinib or adalimumab might be planned Exclusion criteria * History of major cardiovascular events or stroke * History of venous thromboembolism * Active smokers or past smokers \>10 pack/years * History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5) * Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab) * Chronic treatment with moderate to high dose of glucocorticoids (≥7.5 mg/day of prednisone equivalent for more than 3 months prior to enrollment), short term (\<3 months) will be accepted if tapered, as clinically feasible, to \<7.5 mg/day before enrollment)

Locations (1)

Rheumatology Section, University of Verona

Verona, Italy

RECRUITING

Outcomes

Primary Outcomes

micro RNA (miRNA)

Fold increase in miRNA intensity measurements on the base-two logarithmic scale

Time frame: 12 weeks

Secondary Outcomes

Proteomic profile

Fold increase in proteins intensity measurements on the base-two logarithmic scale

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Central Contacts

Giovanni Adami, MD

CONTACT

+390458122574 giovanni.adami@univr.it

Data from ClinicalTrials.gov

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