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NCT Number: NCT06527534

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rheumatology Section, University of Verona

Verona, 37100, Italy

Location status: Recruiting

Location contact

Giovanni Adami, MD

CONTACT

[email protected]

+390458122574

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Filgotinib

Drug

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

Adalimumab

Drug

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

Primary outcomes

  1. micro RNA (miRNA)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Proteomic profile

    Time frame: 12 weeks

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

  2. American College of Rheumatology 20% Improvement (ACR20)

    Time frame: 12 weeks

    Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

  3. Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Time frame: 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)

  4. Disease Activity Score 28 joints measured with CRP (DAS28-CRP)

    Time frame: 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)

  5. 36-Item Short Form Survey (SF-36)

    Time frame: 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)

  6. Functional Assessment of Chronic Illness Therapy (FACIT)

    Time frame: 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)

  7. American College of Rheumatology 50% Improvement (ACR50)

    Time frame: 12 weeks

    Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12

  8. Tender Joint Count

    Time frame: 12 weeks

    Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12

  9. Swollen Joint Count

    Time frame: 12 weeks

    Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12

  10. Subject's Global Assessment of Disease Activity (SGA)

    Time frame: 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)

  11. Physician's Global Assessment of Disease Activity (PGA)

    Time frame: 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)

  12. Pain on Numeric Rating Scale (NRS)

    Time frame: 12 weeks

    Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 12 (range 0 - 10, higher numbers are worse)

  13. Clinical Disease Activity Index (CDAI)

    Time frame: 12 weeks

    Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 12 (range 0 - 76, higher numbers are worse)

  14. Simplified Disease Activity Index (SDAI)

    Time frame: 12 weeks

    Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 12 (range 0 - 91, higher numbers are worse)

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Adami, MD

CONTACT

[email protected]

+390458122574

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study 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)

Acronym: FILRA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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