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Treatment Strategy for Patients With RA-ILD

2026年9月1日 更新者：Chinese SLE Treatment And Research Group

Treatment Strategy for Patients With Rheumatoid Arthritis Associated Interstitial Lung Disease

This is a 52-week, multicenter, prospective, open-label, randomized controlled clinical study, comparing the efficacy and safety of tocilizumab, rituximab, and csDMARD methotrexate in patients with RA-ILD.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a multicenter, randomized, controlled clinical trial designed to evaluate the efficacy and safety of tocilizumab and rituximab in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). A total of 204 eligible participants will be enrolled from 20 centers across China and randomly assigned in a 1:1:1 ratio to one of three treatment arms: (1) tocilizumab in combination with conventional disease-modifying antirheumatic drugs (cDMARDs); (2) rituximab in combination with cDMARDs; or (3) methotrexate added to the participant's pre-existing background immunosuppressive regimen. Each treatment arm will include 68 participants. Participants will be assessed at baseline and at Weeks 4, 12, 24, and 52 following treatment initiation. Efficacy and safety data will be collected throughout the study to evaluate treatment response and tolerability. Safety assessments will include the incidence of adverse events (AEs), serious adverse events (SAEs), treatment discontinuations due to AEs or SAEs, and other clinically relevant safety outcomes.

研究类型

介入性

注册 (估计的)

204

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Xinping Tian
  • 电话号码：+86-13691165939
  • 邮箱：tianxp6@126.com

研究联系人备份

学习地点

  • 中国
      • Beijing、中国
        • Peking Union Medical College Hospital
        • 首席研究员：
          • Xinping Tian
        • 接触：
      • Beijing、中国
        • China-Japan Friendship Hospital
        • 首席研究员：
          • Xin Lu
        • 接触：
          • Xin Lu
      • Beijing、中国
        • Xuanwu Hospital, Capital Medical University
        • 接触：
          • Yi Zhao
        • 首席研究员：
          • Yi Zhao
      • Beijing、中国
        • Beijing Chao-Yang Hospital, Capital Medical University
        • 接触：
          • Juan Meng
        • 首席研究员：
          • juan meng
      • Changchun、中国
        • China-Japan Union Hospital of Jilin University
      • Chongqing、中国
        • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
        • 接触：
          • Qinghua Zou
        • 首席研究员：
          • Qinghua Zou
      • Dalian、中国
        • The Second Affiliated Hospital of Dalian Medical University
        • 接触：
          • Xiaodan Kong
        • 首席研究员：
          • Xiaodan Kong
      • Handan、中国
        • Handan Central Hospital
        • 接触：
          • Xi Liu
        • 首席研究员：
          • Xi Liu
      • Hangzhou、中国
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • 首席研究员：
          • Jing Xue
        • 接触：
          • Jing Xue
      • Hefei、中国
        • The First Affiliated Hospital of Anhui Medical University
        • 接触：
          • Shengqian Xu
        • 首席研究员：
          • Shengqian Xu
      • Hohhot、中国
        • Affiliated Hospital of Inner Mongolia Medical University
        • 接触：
          • Hongbin Li
        • 首席研究员：
          • Hongbin Li
      • Jiujiang、中国
        • Jiujiang No. 1 People's Hospital
        • 接触：
          • Ju Liu
        • 首席研究员：
          • Ju Liu
      • Lanzhou、中国
        • The Second Hospital of Lanzhou University
        • 接触：
          • Haili Shen
        • 首席研究员：
          • Haili Shen
      • Nanchang、中国
        • The Second Affiliated Hospital of Nanchang University
        • 首席研究员：
          • Xinwang Duan
        • 接触：
          • Xinwang Duan
      • Nanjing、中国
        • The First Affiliated Hospital of Nanjing Medical University
        • 首席研究员：
          • Wenfeng Tan
        • 接触：
          • Wenfeng Tan
      • Nanning、中国
        • The First Affiliated Hospital of Guangxi Medical University
        • 首席研究员：
          • Ling Lei
        • 接触：
          • Ling Lei
      • Taiyuan、中国
        • Shanxi Bethune Hospital
        • 接触：
          • Liyun Zhang
        • 首席研究员：
          • Liyun Zhang
      • Xingyi、中国
        • Xingyi People's Hospital
        • 接触：
          • Houli Liao
        • 首席研究员：
          • Houli Liao
      • Yan’an、中国
        • Affiliated Hospital of Yan'an University
        • 接触：
          • Yuhong Liu
        • 首席研究员：
          • Yuhong Liu
      • Yinchuan、中国
        • People's Hospital of Ningxia Hui Autonomous Region
        • 接触：
          • Donggeng Guo
        • 首席研究员：
          • Donggeng Guo
      • Ürümqi、中国
        • The First Affiliated Hospital of Xinjiang Medical University
        • 接触：
          • Li Luo
        • 首席研究员：
          • Li Luo
    • Henan
      • Luoyang、Henan、中国
        • The First Affiliated Hospital of Henan University of Science and Technology
        • 首席研究员：
          • Xiaofei Shi
        • 接触：
          • Xiaofei Shi

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Fulfillment of the 2010 ACR/EULAR classification criteria for RA.
  • HRCT findings consistent with interstitial lung disease (ILD), including ground-glass opacities, reticular abnormalities, fibrotic linear opacities, traction bronchiectasis, or other compatible features, with pulmonary infection, cardiogenic pulmonary edema, and alveolar hemorrhage excluded. The extent of ILD involvement must be ≥20% on HRCT, as assessed by central review.
  • Pulmonary function impairment defined as forced vital capacity (FVC) <80% of predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) <70% of predicted.
  • Participants receiving glucocorticoids prior to enrollment must be on a stable dose of prednisone ≤10 mg/day (or equivalent) for at least 4 weeks before baseline.
  • Participants receiving a csDMARD prior to enrollment must be on a stable regimen for at least 4 weeks before baseline.
  • Able and willing to provide written informed consent and comply with study requirements, including scheduled visits and follow-up assessments.

Exclusion Criteria:

  • Presence of other autoimmune diseases.
  • Presence of severe, uncontrolled clinically significant organ dysfunction or other medical conditions that, in the investigator's judgment, would place the participant at unacceptable risk.
  • History of malignancy within 5 years prior to screening.
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study period.
  • Known hypersensitivity to tocilizumab, telitacicept, methotrexate, or any of their excipients.
  • Active hepatitis B or C virus infection, active tuberculosis, active herpes zoster infection, or a history of serious infection within 12 weeks prior to study treatment initiation (defined as an infection requiring hospitalization or intravenous antimicrobial therapy).
  • Severe hypoalbuminemia or serum immunoglobulin G (IgG) level <6 g/L.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, or creatinine clearance (CrCl) <60 mL/min.
  • Participation in another interventional clinical trial within 4 weeks prior to screening.
  • Inability to adequately perform pulmonary function testing or other study-related assessments.
  • Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
药品：Tocilizumab
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks in addition to stable background csDMARD therapy maintained throughout the study period.
有源比较器：Methotrexate group
Methotrexate will be administered orally at a dose of 15 mg once weekly for 52 weeks in combination with stable background immunosuppressive therapy.
药品：Methotrexate
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
实验性的：Rituximab group
Rituximab will be administered by intravenous infusion at a dose of 1000 mg on Day 0, 1000 mg at Week 2, 500 mg at Week 26, and 500 mg at Week 52, in addition to ongoing treatment with csDMARDs.
药品：Rituximab (RTX)
Rituximab will be administered intravenously at a dose of 1,000 mg on Day 0, 1,000 mg at Week 2, 500 mg at Week 26, and 500 mg at Week 52, in addition to stable background csDMARD therapy maintained throughout the study period.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in FVC from baseline to week 52
大体时间：week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

次要结果测量

结果测量
措施说明
大体时间
Proportion of Participants Experiencing a Composite Clinical Endpoint
大体时间：Up to Week 52 (±2 Weeks)
Composite clinical endpoint defined as the occurrence of at least one of the following events: all-cause mortality, hospitalization for any cause, hospitalization due to progression of respiratory disease, or death due to progression of respiratory disease.
Up to Week 52 (±2 Weeks)
Change in FVC % Predicted from Baseline
大体时间：Baseline to Week 52 (±2)
Change in Percent Predicted Forced Vital Capacity (FVC % Predicted) from baseline to week 52 (±2).
Baseline to Week 52 (±2)
Change in DLCO from Baseline
大体时间：Baseline to Week 52 (±2 Weeks)
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from Baseline.
Baseline to Week 52 (±2 Weeks)
Change in DLCO % Predicted from Baseline
大体时间：Baseline to Week 52 (±2 Weeks)
Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO % Predicted) from Baseline
Baseline to Week 52 (±2 Weeks)
Change in Chest HRCT Score from Baseline
大体时间：Baseline to Week 52 (±2 Weeks)
Change in the total chest high-resolution computed tomography (HRCT) score, inflammatory activity score, and fibrosis score.
Baseline to Week 52 (±2 Weeks)
Change in mMRC Dyspnea Scale Score from Baseline
大体时间：Baseline to Week 52 (±2 Weeks)
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score from Baseline to Week 52 (±2). The mMRC Dyspnea Scale is scored from 0 to 4, with higher scores indicating more severe dyspnea.
Baseline to Week 52 (±2 Weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chinese SLE Treatment And Research Group

调查人员

  • 首席研究员：Xinping Tian、Peking Union Medical College Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月20日

初级完成 (估计的)

2029年7月31日

研究完成 (估计的)

2029年7月31日

研究注册日期

首次提交

2026年6月7日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年9月3日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Strategy on RA-ILD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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