Effects of Filgotinib on Blood Proteins and Micro-RNA in Rheumatoid Arthritis
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)
This study is testing whether the medication Filgotinib can change blood proteins and micro-RNA levels in people with active rheumatoid arthritis compared to another treatment called Adalimumab.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Drugs / interventions | adalimumab, denosumab, romosozumab, filgotinib, prednisone |
| Locations | 1 site (Verona) |
| Trial ID | NCT06527534 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Filgotinib on the proteomic profile and micro-RNA expression in patients with active rheumatoid arthritis. It is a single-center, prospective randomized study involving 30 participants, with half receiving Filgotinib and the other half receiving Adalimumab for comparison. Blood samples will be collected at the start and every four weeks for 12 weeks to analyze changes in proteins and micro-RNA. The primary objective is to observe metabolic profile changes in patients treated with Filgotinib, while secondary objectives include comparing these changes with those in the Adalimumab group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with active rheumatoid arthritis meeting specific disease activity criteria.
Not a fit: Patients with a history of major cardiovascular events, severe osteoporosis, or chronic high-dose glucocorticoid treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how Filgotinib influences inflammation and bone health in rheumatoid arthritis patients.
How similar studies have performed: While this approach is novel in its specific focus on proteomic and micro-RNA changes with Filgotinib, similar studies have shown promise in understanding treatment effects in rheumatoid arthritis.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Verona
- Rheumatology Section, University of Verona — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Adami, MD
- Email: giovanni.adami@univr.it
- Phone: +390458122574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.