Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT06527534

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

Led by Universita di Verona · Updated on 2024-08-01

30

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Rheumatoid arthritis diagnosed according to ACR/EULAR 2010 criteria with active disease (DAS28 CRP >5.1 and/or CDAI >22)
  • Age greater than 18 and less than 65 years
  • Planned treatment with Filgotinib or Adalimumab
Not Eligible

You will not qualify if you...

  • History of major cardiovascular events or stroke
  • History of venous thromboembolism
  • Active smokers or past smokers with more than 10 pack-years
  • History of fragility fractures or severe osteoporosis (T score 3.5 at total hip, femoral neck, or lumbar spine)
  • Treatment with bone-active medications such as estrogens, bisphosphonates, denosumab, teriparatide, or romosozumab
  • Chronic treatment with moderate to high doses of glucocorticoids (7.5 mg/day of prednisone equivalent for more than 3 months before enrollment), though short-term use less than 3 months is allowed if tapered to less than 7.5 mg/day before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rheumatology Section, University of Verona

Verona, Italy, 37100

Actively Recruiting

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Research Team

G

Giovanni Adami, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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