Clinical trial NCT06527534: Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: micro RNA (miRNA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Proteomic profile
timeFrame: 12 weeks
measure: American College of Rheumatology 20% Improvement (ACR20)
timeFrame: 12 weeks
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: 12 weeks
measure: Disease Activity Score 28 joints measured with CRP (DAS28-CRP)
timeFrame: 12 weeks
measure: 36-Item Short Form Survey (SF-36)
timeFrame: 12 weeks
measure: Functional Assessment of Chronic Illness Therapy (FACIT)
timeFrame: 12 weeks
measure: American College of Rheumatology 50% Improvement (ACR50)
timeFrame: 12 weeks
measure: Tender Joint Count
timeFrame: 12 weeks
measure: Swollen Joint Count
timeFrame: 12 weeks
measure: Subject's Global Assessment of Disease Activity (SGA)
timeFrame: 12 weeks
measure: Physician's Global Assessment of Disease Activity (PGA)
timeFrame: 12 weeks
measure: Pain on Numeric Rating Scale (NRS)
timeFrame: 12 weeks
measure: Clinical Disease Activity Index (CDAI)
timeFrame: 12 weeks
measure: Simplified Disease Activity Index (SDAI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Rheumatology Section, University of Verona
Study officials:
References: