方案：对于对甲氨蝶呤反应不足的类风湿关节炎患者，在甲氨蝶呤基础上加用非戈替尼与非戈替尼单药治疗的对比：一项多中心、前瞻性、开放标签、随机对照试验（FAITHFUL研究）
Protocol: Filgotinib in addition to methotrexate versus filgotinib monotherapy in patients with rheumatoid arthritis with an inadequate response to methotrexate: A multicenter, prospective, open-label, randomized controlled trial (FAITHFUL Study).
作者信息
Akiyama Mitsuhiro, Hidaka Toshihiko, Kaneko Motohide, Ito Satoshi, Taguchi Hiroaki, Ishii Tomonori, Asai Shuji, Hirata Shintaro, Ikeda Kei, Suzuki Katsuya, Kato Naoki, Kaneko Yuko
机构信息
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Institute of Rheumatology, Miyazaki Zenjinkai Hospital, Miyazaki, Japan.
出版信息
PLoS One. 2025 May 19;20(5):e0322621. doi: 10.1371/journal.pone.0322621. eCollection 2025.
BACKGROUND
Filgotinib (FIL), a Janus kinase-1 preferential inhibitor, has been studied for its efficacy and safety in rheumatoid arthritis. The FINCH3 trial compared FIL monotherapy, FIL plus methotrexate (MTX) combination therapy, and MTX monotherapy in MTX-naïve patients. However, comparisons in patients with an inadequate response to MTX remain unclear. This study aims to evaluate the efficacy and safety of FIL plus MTX versus FIL monotherapy in patients with rheumatoid arthritis who have an inadequate response to MTX.
METHODS AND ANALYSIS
FAITHFUL (Filgotinib Add-on versus swITcH to Filgotinib in patients with rheUmatoid arthritis who inadequateLy responded to methotrexate) study is a phase IV multicenter, prospective, open-label, randomized controlled trial. Patients with a history of inadequate response to at least 8 weeks of MTX and moderate or high disease activity will be assessed for eligibility at 10 centers in Japan. A history of Janus kinase inhibitor use is an exclusion criterion, but prior use of biologic agents is not considered. Enrolled patients will be randomly assigned in a 1:1 ratio to either the group adding FIL (Add-on group) or the group switching to FIL monotherapy (Switch group). The target sample size is 120 participants. The primary endpoint is the change in DAS28-CRP from baseline to week 24, aiming to assess if the Switch group is non-inferior to the Add-on group. Safety will be evaluated by assessing the incidence of adverse events.
ETHICS AND DISSEMINATION
The study has received approval from the Certified Review Board of Keio University Hospital (N20230002) and adheres to the principles outlined in the Declaration of Helsinki and good clinical practice standards. Prior to enrollment, all participants provide written informed consent. The findings from this study are intended to be submitted for publication in relevant peer-reviewed journals.
TRIAL REGISTRATION
The trial was registered at Japan Registry of Clinical Trials (jRCTs031230673).
背景
非戈替尼（FIL）是一种 Janus 激酶-1 优先抑制剂，已对其在类风湿关节炎中的疗效和安全性进行了研究。FINCH3 试验比较了初治患者使用非戈替尼单药治疗、非戈替尼联合甲氨蝶呤（MTX）治疗以及甲氨蝶呤单药治疗的效果。然而，对于甲氨蝶呤反应不足的患者的比较仍不明确。本研究旨在评估在对甲氨蝶呤反应不足的类风湿关节炎患者中，非戈替尼联合甲氨蝶呤与非戈替尼单药治疗的疗效和安全性。
方法与分析
FAITHFUL（在对甲氨蝶呤反应不足的类风湿关节炎患者中，非戈替尼加用与换用非戈替尼的比较）研究是一项 IV 期多中心、前瞻性、开放标签、随机对照试验。在日本的 10 个中心，将对有至少 8 周甲氨蝶呤反应不足且疾病活动度为中度或高度病史的患者进行资格评估。使用过 Janus 激酶抑制剂的病史是排除标准，但既往使用生物制剂的情况不考虑在内。入组患者将按 1:1 的比例随机分配至加用非戈替尼组（加用组）或换用非戈替尼单药治疗组（换用组）。目标样本量为 120 名参与者。主要终点是从基线到第 24 周 DAS28-CRP 的变化，旨在评估换用组是否不劣于加用组。将通过评估不良事件的发生率来评估安全性。
伦理与传播
该研究已获得庆应义塾大学医院认证审查委员会的批准（N20230002），并遵循《赫尔辛基宣言》和良好临床实践标准中概述的原则。在入组前，所有参与者均提供书面知情同意书。本研究的结果拟提交至相关同行评审期刊发表。
试验注册
该试验已在日本临床试验注册中心（jRCTs031230673）注册。
Zotero 插件