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

NCT06527534 | Recruiting Phase 4

• 1 other identifier: 215CET - FILRA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (1)

• micro RNA (miRNA)

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

  12 weeks

Secondary Outcomes (14)

• Proteomic profile

  12 weeks

• American College of Rheumatology 20% Improvement (ACR20)

  12 weeks

• Health Assessment Questionnaire-Disability Index (HAQ-DI)

  12 weeks

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

  12 weeks

• 36-Item Short Form Survey (SF-36)

  12 weeks

Study Arms (2)

Filgotinib

EXPERIMENTAL

Filgotinib 200 mg qd

Drug: Filgotinib

Adalimumab

ACTIVE COMPARATOR

Adalimumab 40 mg q2wk

Drug: Adalimumab

Interventions

Filgotinib DRUG

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

Filgotinib

Adalimumab DRUG

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

Adalimumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Rheumatology Section, University of Verona

Verona, 37100, Italy

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GLPG0634; Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Giovanni Adami, MD

CONTACT

+390458122574; giovanni.adami@univr.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: July 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: September 15, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)