Rheumatoid Arthritis
Conditions
Keywords
RA
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.
Detailed description
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.
Interventions
DRUGFilgotinib
Patients will receive pills of Filgotinib 200 mg qd for 12 weeks
DRUGAdalimumab
Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| micro RNA (miRNA) | 12 weeks | Fold increase in miRNA intensity measurements on the base-two logarithmic scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 20% Improvement (ACR20) | 12 weeks | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) | 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) |
| Disease Activity Score 28 joints measured with CRP (DAS28-CRP) | 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) |
| 36-Item Short Form Survey (SF-36) | 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) |
| Functional Assessment of Chronic Illness Therapy (FACIT) | 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) |
| American College of Rheumatology 50% Improvement (ACR50) | 12 weeks | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12 |
| Proteomic profile | 12 weeks | Fold increase in proteins intensity measurements on the base-two logarithmic scale |
| Swollen Joint Count | 12 weeks | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12 |
| Subject's Global Assessment of Disease Activity (SGA) | 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) |
| Physician's Global Assessment of Disease Activity (PGA) | 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) |
| Pain on Numeric Rating Scale (NRS) | 12 weeks | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 12 (range 0 - 10, higher numbers are worse) |
| Clinical Disease Activity Index (CDAI) | 12 weeks | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 12 (range 0 - 76, higher numbers are worse) |
| Simplified Disease Activity Index (SDAI) | 12 weeks | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 12 (range 0 - 91, higher numbers are worse) |
| Tender Joint Count | 12 weeks | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12 |
Countries
Italy
Contacts
Primary ContactGiovanni Adami, MD
Outcome results
None listed