NCT06527534 Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
| NCT ID | NCT06527534 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universita di Verona |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2025-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2024-07-15 with a primary completion date of 2025-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06527534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06527534 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06527534 currently recruiting?
Yes, NCT06527534 is actively recruiting participants. Contact the research team at giovanni.adami@univr.it for enrollment information.
Where is the NCT06527534 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT06527534 clinical trial?
NCT06527534 is sponsored by Universita di Verona. The trial plans to enroll 30 participants.
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