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)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- micro RNA (miRNA)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Filgotinib
Filgotinib 200 mg qd
干预措施: Filgotinib (Drug)
Adalimumab
Adalimumab 40 mg q2wk
干预措施: Adalimumab (Drug)
结局指标
主要结局
micro RNA (miRNA)
时间窗: 12 weeks
Fold increase in miRNA intensity measurements on the base-two logarithmic scale
次要结局
- 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)
- Functional Assessment of Chronic Illness Therapy (FACIT)(12 weeks)
- American College of Rheumatology 50% Improvement (ACR50)(12 weeks)
- Tender Joint Count(12 weeks)
- Swollen Joint Count(12 weeks)
- Subject's Global Assessment of Disease Activity (SGA)(12 weeks)
- Physician's Global Assessment of Disease Activity (PGA)(12 weeks)
- Pain on Numeric Rating Scale (NRS)(12 weeks)
- Clinical Disease Activity Index (CDAI)(12 weeks)
- Simplified Disease Activity Index (SDAI)(12 weeks)
研究者
Giovanni Adami
Principal Investigator
Universita di Verona