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巴瑞克替尼在类风湿性关节炎患者中的研究 (RA-BRANCH)

2026年6月15日 更新者：Eli Lilly and Company

Baricitinib 在类风湿性关节炎患者中的随机、对照实用 3b/4 期研究

这项上市后研究旨在比较巴瑞克替尼与肿瘤坏死因子 (TNF) 抑制剂在静脉血栓栓塞事件 (VTE) 方面对类风湿关节炎 (RA) 患者的安全性。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

1050

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。

学习地点

  • 美国
    • Arizona
      • Chandler、Arizona、美国、85225
        • Arizona Research Clinic PLLC
      • Mesa、Arizona、美国、85202
        • Arizona Arthritis & Rheumatology Associates, P. C.
      • Paradise Valley、Arizona、美国、85253
        • Arizona Arthritis & Rheumatology Research
      • Peoria、Arizona、美国、85381
        • Sun Valley Arthritis Center, LTD
      • Phoenix、Arizona、美国、85037
        • Arizona Arthritis & Rheumatology Associates
    • Arkansas
      • Jonesboro、Arkansas、美国、72401
        • Arthritis and Rheumatism Associates
    • California
      • Burbank、California、美国、91505
        • Providence St. Joseph's Medical Center
      • Canoga Park、California、美国、91303
        • Hope Clinical Research, Inc.
      • Covina、California、美国、91722
        • Medvin Clinical Research - Covina
      • El Cajon、California、美国、92020
        • Triwest Research Associates LLC
      • Huntington Beach、California、美国、92648
        • Newport Huntington Med Grp
      • La Mesa、California、美国、91942
        • BioSolutions Clinical Research Center
      • Los Alamitos、California、美国、90720
        • Valerius Medical Group and Research Center of Greater Long Beach
      • Monterey Park、California、美国、91754
        • R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
      • Poway、California、美国、92064
        • ACRC Studies
      • Rancho Mirage、California、美国、92270
        • Desert Medical Advances
      • San Diego、California、美国、92120
        • Purushotham & Akther Kotha MD Inc
      • San Leandro、California、美国、94578
        • East Bay Rheumatology Medical Group, Inc
      • Santa Rosa、California、美国、95403
        • Providence Medical Foundation
      • Tujunga、California、美国、91042
        • Dan La, MD Inc
      • Tustin、California、美国、92780
        • Office: Dr Robin K Dore
      • Upland、California、美国、91786
        • Inland Rheumatology & Osteoporosis Medical Group
      • West Hills、California、美国、91307
        • Nazanin Firooz, MD Inc.
      • Whittier、California、美国、90602
        • Medvin Clinical Research - Whittier
    • Connecticut
      • Danbury、Connecticut、美国、06810
        • Danbury Clinical Research, LLC
    • Delaware
      • Lewes、Delaware、美国、19958
        • Delaware Arthritis
    • Florida
      • DeBary、Florida、美国、32713
        • Omega Research Debary, LLC
      • Fort Lauderdale、Florida、美国、33334
        • Cria Center for Rheumatology
      • Gainesville、Florida、美国、32607
        • SIMED Health
      • Hollywood、Florida、美国、33024
        • GNP Research at Mark Jaffe, MD
      • Lake Worth、Florida、美国、33467 2991
        • Rheumatology Center Of Palm Beach, Pllc
      • Margate、Florida、美国、33063
        • Arthritis and Rheumatology Center of South Florida
      • Miami、Florida、美国、33185
        • Felicidad Medical Research
      • Miami、Florida、美国、33155
        • Miami Clinical Reserach
      • Orlando、Florida、美国、32806
        • Rheumatology Associates of Central Florida
      • Orlando、Florida、美国、32819
        • Heuer MD Research
      • Orlando、Florida、美国、32827
        • UCF Health Lake Nona Orlando
      • Plantation、Florida、美国、33324
        • IRIS Research and Development, LLC
      • St. Petersburg、Florida、美国、33705
        • BayCare Health System Inc
      • Tamarac、Florida、美国、33321
        • West Broward Rheumatology Associates
      • Tampa、Florida、美国、33613
        • Avita Clinical Research
      • Tampa、Florida、美国、33614
        • Tampa Medical Group, P.A.
      • Zephyrhills、Florida、美国、33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta、Georgia、美国、30342
        • Arthritis & Rheumatology of Georgia
      • Gainesville、Georgia、美国、30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise、Idaho、美国、83702
        • St Luke's Clinic - Intermountain Orthopaedics
    • Illinois
      • Hinsdale、Illinois、美国、60521
        • Hinsdale Orthopaedics, Illinois Bone and Joint
      • Rockford、Illinois、美国、61114
        • OrthoIllinois
      • Rockford、Illinois、美国、61107
        • Rockford Orthopedic Associates
      • Schaumburg、Illinois、美国、60195
        • Greater Chicago Specialty Physicians, LLC
      • Skokie、Illinois、美国、60076
        • Center of Robert Hozman
    • Indiana
      • South Bend、Indiana、美国、46617
        • Beacon Medical Group Clinical Research
    • Kentucky
      • Bowling Green、Kentucky、美国、42101
        • Graves-Gilbert Clinic
      • Hopkinsville、Kentucky、美国、42240
        • Western KY Rheumatology PLLC
    • Louisiana
      • Lake Charles、Louisiana、美国、70605
        • Accurate Clinical Research
      • Monroe、Louisiana、美国、71203
        • Arthritis and Diabetes Clinic, Inc.
      • New Orleans、Louisiana、美国、70121
        • Ochsner Clinic Foundation
    • Maryland
      • Cumberland、Maryland、美国、21502
        • Klein and Associates MD, PA
    • Massachusetts
      • Fall River、Massachusetts、美国、02721
        • NECCR PrimaCare Research
    • Michigan
      • Grand Blanc、Michigan、美国、48439
        • Michigan Rheumatology Group
      • Okemos、Michigan、美国、48864
        • Pandit Rheumatology PC
    • Missouri
      • Jefferson City、Missouri、美国、65109
        • Jefferson City Medical Group
      • Springfield、Missouri、美国、65807
        • Clinvest Research LLC
      • St Louis、Missouri、美国、63131
        • West County Rheumatology
    • Nevada
      • Henderson、Nevada、美国、89104
        • Lovelace Scientific Resources
      • Reno、Nevada、美国、89519
        • Allied Clinical Research
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Somerset、New Jersey、美国、08873
        • Arthritis Care Medical Center
      • Toms River、New Jersey、美国、08757
        • Atlantic Coastal Research
      • West Long Branch、New Jersey、美国、07764
        • Sahni Rheumatology & Therapy PC
    • New York
      • New York、New York、美国、10016
        • NYU Langone
    • North Carolina
      • Greensboro、North Carolina、美国、27408
        • Medication Management
      • Hickory、North Carolina、美国、28601
        • PMG Research of Hickory, LLC
      • Leland、North Carolina、美国、28451
        • Cape Fear Arthritis Care
      • Wilmington、North Carolina、美国、28401
        • Carolina Arthritis Associates
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • Cincinnati Arthritis Associates
      • Marion、Ohio、美国、43302
        • Craig S Thompson MD LLC
      • Middleburg Heights、Ohio、美国、44130
        • Paramount Medical Research
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73103
        • Arthritis & Rheumatology Center of Oklahoma PLLC
    • Oregon
      • Corvallis、Oregon、美国、97330
        • Good Samaritan Hospital Corvallis
    • Pennsylvania
      • Cranberry Township、Pennsylvania、美国、15090
        • Advanced Rheumatology and Arthritis Research Center, PC
      • Duncansville、Pennsylvania、美国、16635
        • Altoona Center for Clinical Research
      • Wyomissing、Pennsylvania、美国、19610
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
    • South Carolina
      • North Charleston、South Carolina、美国、29406
        • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
    • South Dakota
      • Rapid City、South Dakota、美国、57701
        • Monument Health Rapid City Hospital
    • Tennessee
      • Crossville、Tennessee、美国、38555
        • Cumberland Rheumatology
      • Jackson、Tennessee、美国、38305
        • West Tennessee Research Institute
      • Nashville、Tennessee、美国、37203
        • Nashville Arthritis and Rheumatology
    • Texas
      • Allen、Texas、美国、75013
        • Accent Clinical Research Professionals, LLC
      • Amarillo、Texas、美国、79124
        • Amarillo Center for Clinical Research
      • College Station、Texas、美国、77845
        • Arthritis & Osteoporosis Clinic of Brazos Valley
      • Dallas、Texas、美国、75235
        • Metroplex Clinical Research Center
      • El Paso、Texas、美国、79912
        • El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
      • Houston、Texas、美国、77008
        • Pioneer Research Solutions
      • Houston、Texas、美国、77043
        • Biopharma Informatic, LLC
      • Houston、Texas、美国、77084
        • Accurate Clinical Management - Houston
      • Houston、Texas、美国、77002
        • UDL Clinical Research, LLC
      • Katy、Texas、美国、77494
        • Houston Rheumatology & Arthritis Specialists
      • Katy、Texas、美国、77494
        • R and H Clinical Research
      • Katy、Texas、美国、77450
        • Synergy Group US
      • Mansfield、Texas、美国、76063
        • Prime Clinical Research
      • Mesquite、Texas、美国、75150
        • Southwest Rheumatology, P.A.
      • Pearland、Texas、美国、77584
        • Advanced Clinical Research Center of Houston
      • Plano、Texas、美国、75007
        • Clinrx Research Joseph INC.
      • Pleasanton、Texas、美国、78064
        • Violeta T. Baddour, MD
      • San Antonio、Texas、美国、78229
        • Accurate Clinical Research, Inc.
      • Sugar Land、Texas、美国、77479
        • Mt. Olympus Medical Research
      • Sugar Land、Texas、美国、77479
        • Fort Bend Clinical Research, LLC
      • Sugar Land、Texas、美国、77479
        • Accurate Clinical Management
      • Temple、Texas、美国、76508
        • Baylor Scott & White Health
      • The Woodlands、Texas、美国、77380
        • North Houston Rheumatology Associates
      • Tomball、Texas、美国、77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Virginia
      • Chesapeake、Virginia、美国、23320
        • Center for Arthritis and Rheumatic Diseases, PC
      • Danville、Virginia、美国、24541
        • Spectrum Medical Inc.
      • Manassas、Virginia、美国、20109
        • Arthritis & Osteoporosis Center of Northern Virinia
      • Newport News、Virginia、美国、23606
        • TPMG Rheumatology/TPMG Clinical Research
    • Washington
      • Spokane、Washington、美国、99204
        • Arthritis Northwest, PLLC
    • West Virginia
      • Beckley、West Virginia、美国、25801
        • Rheumatology & Pulmonary Clinic
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53211
        • Rheumatic Disease Center

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 参与者必须至少具有以下特征之一：

    • 本研究之前有 VTE 的书面证据
    • 至少60岁
    • 体重指数 (BMI) 大于或等于 30 公斤每平方米 (kg/m²)，或
    • 50 岁至 60 岁以下且 BMI 25 至 30 公斤/平方米以下
  • 参与者必须对至少一种缓解疾病的抗风湿药 (DMARD)（合成或生物）反应不足或不耐受

排除标准：

  • 参与者之前不得使用过 Janus 激酶 (JAK) 抑制剂或接受过 1 种以上的 TNF 抑制剂：

    • 因 RA 的 IR（疗效缺乏或丧失）而停药，或
    • 用于任何适应症时因不耐受 (AE) 而停产
  • 参加者不得怀孕或哺乳
  • 参与者不得有超过一次的 VTE
  • 参与者不得患有癌症
  • 参与者不得患有活动性带状疱疹、严重感染、活动性肺结核或任何其他严重疾病
  • 参与者不得在研究开始后的四个星期内接种过活疫苗
  • 参与者不得在研究开始后的四个星期内参加任何其他临床试验
  • 参加者在过去一年中不得有静脉吸毒史、其他非法药物滥用史或长期酗酒史

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：Baricitinib 4mg
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
药品：巴瑞克替尼
口服给药。
其他名称：
  • LY3009104
有源比较器：Tumor Necrosis Factor (TNF) Inhibitor
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
药品：TNF Inhibitor
Administered subcutaneously.
其他名称：
  • 依那西普
  • 阿达木单抗
实验性的：Baricitinib 2mg
Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
药品：巴瑞克替尼
口服给药。
其他名称：
  • LY3009104

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
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
大体时间：From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

次要结果测量

结果测量
措施说明
大体时间
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
大体时间：From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first ATE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
大体时间：From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first MACE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
大体时间：From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first malignancy (excluding NMSC) was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
大体时间：From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first opportunistic infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
大体时间：From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first serious infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
大体时间：From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

其他结果措施

结果测量
措施说明
大体时间
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
大体时间：From the date of first dose of study drug up to the last dose (approximately up to 5.3 years)

Duration of exposure was calculated as:

  • Baricitinib 2mg exposure = date of last baricitinib 2mg treatment - date of first baricitinib 2mg dose + 1. For participants who were rescued from baricitinib 2 mg to 4 mg, their drug exposure after rescue was censored and not counted as exposure to baricitinib 2mg.
  • Baricitinib 4mg exposure = date of last baricitinib 4mg treatment - date of first baricitinib 4mg dose + 1.

TNF inhibitor exposure = date of last TNFi (adalimumab or etanercept) - date of first TNFi dose (adalimumab or etanercept) + 1, regardless of treatment cycling from adalimumab to etanercept or vice versa.

- Total baricitinib exposure (2/4 mg) = date of last baricitinib (2mg or 4mg) treatment - date of first baricitinib (2mg or 4mg) dose + 1, regardless of rescue from baricitinib 2mg to baricitinib 4mg.

Patient-years is calculated as sum of duration of exposure in days for all patients in dosing regimen divided by 365.25.
From the date of first dose of study drug up to the last dose (approximately up to 5.3 years)

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

Eli Lilly and Company

合作者

Incyte Corporation

调查人员

  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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 (实际的)

2020年2月14日

初级完成 (实际的)

2025年5月19日

研究完成 (实际的)

2025年5月19日

研究注册日期

首次提交

2019年9月10日

首先提交符合 QC 标准的

2019年9月10日

首次发布 (实际的)

2019年9月12日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 17363
  • I4V-MC-JAJD (其他标识符：Eli Lilly and Company)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。

IPD 共享时间框架

数据在美国和欧盟研究的适应症首次公布和批准后 6 个月提供，以较晚者为准。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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