此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一项针对中度至重度类风湿性关节炎参与者的研究 (RA-BUILD)

2019年9月9日 更新者：Eli Lilly and Company

一项随机、双盲、安慰剂对照的 3 期研究，旨在评估 Baricitinib (LY3009104) 在对常规疾病缓解抗风湿药反应不佳的中度至重度活动性类风湿性关节炎患者中的疗效和安全性

本研究的目的是确定 baricitinib 4 毫克 (mg) 每天一次 (QD) 是否优于安慰剂治疗患有中度至重度活动性类风湿性关节炎 (RA) 的参与者，这些参与者对下列药物反应不足或不耐受至少 1 名常规疾病缓解抗风湿药 (cDMARD)（cDMARD-IR [反应不足] 参与者）且未接受生物疾病缓解抗风湿药 (DMARD)。

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)

684

阶段

  • 第三阶段

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

  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、115522
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Petersburg、俄罗斯联邦、194291
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ulyanovsk、俄罗斯联邦、432063
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Yaroslavl、俄罗斯联邦、150003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 克罗地亚
      • Karlovac、克罗地亚、47000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Osijek、克罗地亚、31000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Varazdin、克罗地亚、42000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zagreb、克罗地亚、10 000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 加拿大
    • British Columbia
      • Kelowna、British Columbia、加拿大、V1Y3G5
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Victoria、British Columbia、加拿大、V8V 3P9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3A 1M3
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ontario
      • Kitchener、Ontario、加拿大、N2M 5N6
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ottawa、Ontario、加拿大、K1H 1A2
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toronto、Ontario、加拿大、M5T 2S8
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Quebec
      • Quebec City、Quebec、加拿大、G1W 4R4
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Trois-Rivieres、Quebec、加拿大、G8Z 1Y2
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Saskatchewan
      • Saskatoon、Saskatchewan、加拿大、S7K 0H6
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 匈牙利
      • Bekescsaba、匈牙利、5600
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Budapest、匈牙利、1023
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Debrecen、匈牙利、4043
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szekesfehervar、匈牙利、8000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Veszprem、匈牙利、8200
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 印度
      • Ahmedabad、印度、532004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Attavar, Mangalore、印度、575001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bangalore、印度、560 054
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Belgaum、印度、590 010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gurgaon、印度、122001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hyderabaad、印度、500072
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jaipur、印度、302006
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kolkata、印度、700 020
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lucknow、印度、226018
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mumbai、印度、400053
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Secunderabad、印度、500 003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 台湾
      • Kaohsiung City、台湾、83301
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Neihu Taipei、台湾、114
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung、台湾、404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung City、台湾、40201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taipei、台湾、10630
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Yong Kung City、台湾、71004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 墨西哥
      • Mexicali、墨西哥、21200
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mexico City、墨西哥、06600
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 大韩民国
      • Gwangju、大韩民国、510-757
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Incheon、大韩民国、400-711
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul、大韩民国、150-713
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 德国
      • Gommern、德国、39245
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Köln、德国、50937
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Würzburg、德国、97080
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 意大利
      • Milano、意大利、20157
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Prato、意大利、50047
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rozzano、意大利、20089
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valeggio Sul Mincio、意大利、37067
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 捷克语
      • Brno、捷克语、61141
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hustopece、捷克语、693 01
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pardubice、捷克语、530 02
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Uherske Hradiste、捷克语、686 01
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 斯洛伐克
      • Bratislava、斯洛伐克、83103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Partizanske、斯洛伐克、95801
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Topolcany、斯洛伐克、95501
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 日本
      • Aichi、日本、470-1192
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hiroshima、日本、730-0017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hokkaido、日本、060-8648
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kagawa、日本、761-0793
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Okayama、日本、700-8607
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saitama、日本、359-1111
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tochigi、日本、329- 0498
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tokyo、日本、104-8560
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toyama、日本、933-0874
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 比利时
      • Genk、比利时、3600
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gent、比利时、9000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Merksem、比利时、2170
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mons、比利时、7000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 波兰
      • Bydgoszcz、波兰、85-168
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Elblag、波兰、82-300
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gdansk、波兰、80-546
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lodz、波兰、90-242
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nadarzyn、波兰、05-830
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 波多黎各
      • Caguas、波多黎各、00725
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San German、波多黎各、00683
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Juan、波多黎各、00918
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santurce、波多黎各、00909
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 澳大利亚
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、2050
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Queensland
      • Maroochydore、Queensland、澳大利亚、4558
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 罗马尼亚
      • Bucharest、罗马尼亚、011172
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cluj-Napoca、罗马尼亚、400006
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Constanta、罗马尼亚、900591
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 美国
    • Arizona
      • Glendale、Arizona、美国、85304
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Peoria、Arizona、美国、85381
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Phoenix、Arizona、美国、85023
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tucson、Arizona、美国、85724
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • California
      • Fresno、California、美国、93720
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • La Jolla、California、美国、92037
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Palm Desert、California、美国、92260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santa Maria、California、美国、93454
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Upland、California、美国、91786
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Boulder、Colorado、美国、80304
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Denver、Colorado、美国、80230
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Connecticut
      • Danbury、Connecticut、美国、06810
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Trumbull、Connecticut、美国、06611
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Delaware
      • Lewes、Delaware、美国、19958
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Boynton Beach、Florida、美国、33472
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Naples、Florida、美国、34102
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • New Port Richey、Florida、美国、34652
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Orlando、Florida、美国、32806
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Palm Harbor、Florida、美国、34684
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tampa、Florida、美国、33614
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Vernon Hills、Illinois、美国、60061
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Michigan
      • Kalamazoo、Michigan、美国、49009
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lansing、Michigan、美国、48910
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Columbia、Missouri、美国、65212
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Louis、Missouri、美国、63117
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Jersey
      • Freehold、New Jersey、美国、07728
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toms River、New Jersey、美国、08755
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Albany、New York、美国、12206
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hartsdale、New York、美国、10530
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Asheville、North Carolina、美国、28803
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Charlotte、North Carolina、美国、28207
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Middleburg Heights、Ohio、美国、44130
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oklahoma
      • Tulsa、Oklahoma、美国、74135
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oregon
      • Portland、Oregon、美国、97239
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Bethlehem、Pennsylvania、美国、18017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wyomissing、Pennsylvania、美国、19610
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Carolina
      • Myrtle Beach、South Carolina、美国、29572
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Cypress、Texas、美国、77429
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Dallas、Texas、美国、75231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lubbock、Texas、美国、79424
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nassau Bay、Texas、美国、77058
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Webster、Texas、美国、77508
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Virginia
      • Chesapeake、Virginia、美国、23320
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Washington
      • Kennewick、Washington、美国、99336
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vancouver、Washington、美国、98664
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Wisconsin
      • Franklin、Wisconsin、美国、53132
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 英国
    • England
      • London、England、英国、SE1 9RT
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Hampshire
      • Basingstoke、Hampshire、英国、RG24 9NA
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tyneside
      • North Shields、Tyneside、英国、NE29 8NH
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 葡萄牙
      • Almada、葡萄牙、2805-267
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ponte De Lima、葡萄牙、4990-041
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 西班牙
      • Bilbao、西班牙、48013
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Getafe、西班牙、28905
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santander、西班牙、39008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valencia、西班牙、46026
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Villajoyosa、西班牙、03570
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 阿根廷
      • Buenos Aires、阿根廷、C1128AAF
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Córdoba、阿根廷、5000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Quilmes、阿根廷、B1878DVC
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tucuman、阿根廷、4000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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

有资格学习的性别

全部

描述

纳入标准：

  • 根据美国风湿病学会/欧洲抗风湿病联盟 (ACR/EULAR) 2010 年 RA 分类标准的定义，诊断为成人发作的类风湿性关节炎 (RA)
  • 具有中度至重度活动性 RA，定义为存在至少 6/68 个触痛关节和至少 6/66 个肿胀关节
  • C反应蛋白（CRP）或高敏C反应蛋白（hsCRP）测量值≥（大于或等于）正常值上限（ULN）的1.2倍

  • 对常规疾病缓解抗风湿药 (cDMARD) 反应不足或不耐受，并且：

    • 在进入研究前至少 12 周内定期使用 cDMARD，并且在进入研究前至少 8 周内连续、不变地使用剂量
    • 对于在进入时未接受 cDMARD 的参与者，研究者将在参与者的历史记录中记录参与者失败、无法耐受或有 cDMARD 治疗禁忌症

排除标准：

  • 目前正在接受剂量 >（大于）10 毫克/天的泼尼松（或同等剂量）的皮质类固醇，或者在进入研究后 2 周内或计划随机分组后 6 周内接受不稳定的皮质类固醇给药方案
  • 在进入研究后 2 周内或计划随机分组后 6 周内开始使用非甾体抗炎药 (NSAID) 治疗或接受不稳定的 NSAID 给药方案
  • 目前正在接受甲氨蝶呤 (MTX)、羟氯喹和柳氮磺胺吡啶或任何 3 种 cDMARD 的联合治疗
  • 曾经接受过任何生物 DMARD
  • 在进入研究前 4 周内接受过干扰素治疗或预计在研究期间需要干扰素治疗
  • 在进入研究前 2 周内或在计划随机分组前 6 周内接受过任何通过肌内或静脉内 (IV) 注射的肠外皮质类固醇，或预计在研究期间需要肠外注射皮质类固醇
  • 在进入研究前 2 周内或计划随机分组前 6 周内，有 3 个或更多关节注射了关节内皮质类固醇或透明质酸
  • 有活动性纤维肌痛，在研究者看来，这将使得难以为本研究的目的适当评估 RA 活动
  • 诊断出除 RA 以外的任何全身炎症性疾病，例如但不限于幼年慢性关节炎、脊柱关节病、克罗恩病、溃疡性结肠炎、银屑病关节炎、活动性血管炎或痛风（不排除患有继发性干燥综合征的参与者。）
  • 诊断为 Felty 综合征
  • 在进入研究后的 8 周内接受过任何大手术，或者在研究期间需要进行大手术，研究者在与礼来公司或其指定人员协商后认为会对参与者造成不可接受的风险
  • 在进入研究后的 12 周内经历过以下任何一种情况：心肌梗塞、不稳定的缺血性心脏病、中风或患有纽约心脏协会 IV 期心力衰竭
  • 有心血管、呼吸系统、肝脏、胃肠道、内分泌、血液学、神经学或神经精神疾病或任何其他严重和/或不稳定疾病的病史或存在，研究者认为这些疾病可能在服用研究产品时构成风险或可能会干扰数据的解释
  • 大部分或完全丧失行为能力，几乎无法自我照顾，例如卧床不起或只能坐在轮椅上
  • 使用肾病饮食改良 (MDRD) 方法，根据最近可用的血清肌酐估计肾小球滤过率 (eGFR) <（小于）40 毫升每分钟每 1.73 m^2 (mL/min/1.73 米^2)
  • 有慢性肝病病史，最近可用的天冬氨酸转氨酶 (AST) 或丙氨酸转氨酶 (ALT) > ULN 的 1.5 倍或最近可用的总胆红素 >/= ULN 的 1.5 倍
  • 有淋巴增生性疾病病史；或有提示可能存在淋巴增生性疾病的体征或症状，包括淋巴结肿大或脾肿大；或患有活动性原发性或复发性恶性疾病；或临床上显着的恶性肿瘤已缓解 <5 年
  • 在计划随机化之前的 12 周内已经接触过活疫苗，或者预计在研究过程中需要/接受活疫苗（带状疱疹疫苗接种除外）
  • 目前或最近有临床上严重的病毒、细菌、真菌或寄生虫感染
  • 在进入研究前 12 周内曾有症状性带状疱疹感染
  • 有播散性/复杂性带状疱疹病史（例如，多皮节受累、眼部带状疱疹、中枢神经系统受累、带状疱疹后遗神经痛）
  • 免疫功能低下，并且研究者认为参与研究的风险不可接受
  • 有活动性乙型肝炎病毒 (HBV)、丙型肝炎病毒 (HCV) 或人类免疫缺陷病毒 (HIV) 病史
  • 筛选实验室测试值，包括促甲状腺激素 (TSH)，超出人群或研究地点的参考范围，研究者认为这对参与者参与研究构成不可接受的风险
  • 有筛查心电图 (ECG) 异常，研究者或申办者认为这些异常具有临床意义，表明参与者参与研究存在不可接受的风险（例如，Fridericia 的校正 QT 间期 >500 毫秒 [msec]，男性和>520 毫秒（女性）
  • 在参加研究时患有有症状的单纯疱疹
  • 有活动性或潜伏性结核病 (TB) 的证据

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：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂

安慰剂每天口服一次，直至第 24 周。 从第 16 周开始，无反应的参与者将在第 24 周期间每天口服一次 4 毫克 (mg) 巴瑞克替尼。

在整个研究过程中，参与者将继续接受背景常规疾病缓解抗风湿药 (cDMARD) 治疗。
药品：安慰剂
口服给药
药品：cDMARD
作为背景疗法的常规疾病缓解抗风湿药
实验性的：巴瑞克替尼 2 毫克

Baricitinib 2 mg，每天口服一次，直至第 24 周。 从第 16 周开始，无反应的参与者将在第 24 周期间每天一次口服 4 mg baricitinib 来挽救。

参与者将在整个研究过程中继续接受背景 cDMARD 治疗。
药品：巴瑞克替尼
口服给药
其他名称：
  • INCB 028050
  • LY 3009104
药品：cDMARD
作为背景疗法的常规疾病缓解抗风湿药
实验性的：巴瑞克替尼 4 毫克

Baricitinib 4 mg，每天口服一次，直至第 24 周。 从第 16 周开始，无反应的参与者将在第 24 周期间每天口服 4 mg baricitinib 来挽救。

参与者将在整个研究过程中继续接受背景 cDMARD 治疗。
药品：巴瑞克替尼
口服给药
其他名称：
  • INCB 028050
  • LY 3009104
药品：cDMARD
作为背景疗法的常规疾病缓解抗风湿药

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
达到美国风湿病学会 20% 改善 (ACR20) 的参与者百分比
大体时间：第 12 周
ACR20 反应指数是类风湿性关节炎 (RA) 的临床、实验室和功能测量的综合结果。 “ACR20 响应者”是指在压痛和肿胀关节计数方面至少有 20% 改善并且符合以下 5 项标准中的至少 3 项的参与者：医生对疾病活动的整体评估、患者使用视觉模拟量表对疾病活动的整体评估（ VAS）、健康评估问卷-残疾指数（HAQ-DI）、关节炎引起的疼痛和高敏 C 反应蛋白（hsCRP）。 缺少反应的参与者和停止研究或药物或在分析时间点之前获救的参与者被视为无反应者。
第 12 周

次要结果测量

结果测量
措施说明
大体时间
基于 28 关节计数和高灵敏度 C 反应蛋白 (DAS28-hsCRP) 的疾病活动评分相对于基线的变化
大体时间：基线，第 12 周
疾病活动评分 (DAS) 修改为包括 28 个关节计数 (DAS28)，由以下变量的综合评分组成：触痛关节计数 (TJC28)、肿胀关节计数 (SJC28)、C 反应蛋白 (CRP)（毫克/升）、以及患者使用视觉模拟量表 (VAS) 对疾病活动的整体评估（参与者全局 VAS）。 使用以下公式计算 DAS28：DAS28-CRP=0.56*square 根 (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*自然 log(CRP+1)+0.014*患者的 全球 VAS+0.96。 分数范围为 1.0-9.4， 其中较低的分数表示较少的疾病活动。
基线，第 12 周
健康评估问卷-残疾指数 (HAQ-DI) 分数相对于基线的变化
大体时间：基线，第 12 周
HAQ-DI 问卷评估参与者在穿衣和打扮时对困难程度的自我感知（0 [没有任何困难]、1 [有一些困难]、2 [有很多困难] 和 3 [无法做到]） 、起床、进食、行走、卫生、伸手、抓握和进行其他日常活动。 每个功能区域的分数被平均以计算 HAQ-DI 分数，其范围从 0（无残疾）到 3（最严重的残疾）。 HAQ-DI 分数的下降表明参与者的状况有所改善。
基线，第 12 周
达到简化疾病活动指数 (SDAI) ≤3.3 的参与者百分比
大体时间：第 12 周
SDAI 是一种用于测量 RA 疾病活动的工具，它整合了 TJC28、SJC28、使用 C 反应蛋白（毫克/升）的急性期反应、参与者使用 VAS 厘米 (cm) 对疾病活动的整体评估以及医生对疾病的整体评估使用 VAS 的活动 (cm)。 SDAI 是通过将 5 个分量的值相加计算得出的。 较低的分数表示较少的疾病活动。 基于指数的缓解定义发生在 SDAI 评分≤3.3 时。
第 12 周
电子日记中收集的前 7 天清晨关节僵硬 (MJS) 的平均持续时间
大体时间：第 12 周
参与者在每日电子日记中以小时和分钟为单位报告了他们早晨关节僵硬 (MJS) 的持续时间。 如果 MJS 持续时间超过 12 小时（720 分钟），则将其截断为 720 分钟以进行统计展示和分析。 计算每次就诊前 7 天的平均值。 MJS 持续时间的减少表明参与者的状况有所改善。
第 12 周
电子日记中收集的前 7 天清晨关节僵硬数字评定量表 (NRS) 的平均严重程度
大体时间：第 12 周
参与者通过选择 0 到 10 之间的一个数字来评估他们的 MJS 严重程度，该数字最能描述他们从醒来时起的 MJS 总体水平，其中 0 代表“没有关节僵硬”，10 代表“关节僵硬到你能想象的那么严重” ”。 参与者每天在电子日记中报告他们的严重程度。 计算每次就诊前 7 天的平均值。 严重程度的下降表明参与者的状况有所改善。
第 12 周
电子日记中收集的前 7 天平均最疲倦数字评定量表 (NRS)
大体时间：第 12 周
参与者通过从 0 到 10 中选择一个最能描述他们在过去 24 小时内最严重疲劳程度的数字来评估他们的疲劳程度，其中 0 代表“没有疲劳”，10 代表“你能想象到的最糟糕”。 参与者在每日电子日记中报告了他们最严重的疲劳。 计算每次就诊前 7 天的平均值。 疲劳严重程度等级的降低表明参与者的状况有所改善。
第 12 周
电子日记中收集的前 7 天平均最严重关节疼痛数字评定量表 (NRS)
大体时间：第 12 周
参与者通过从 0 到 10 中选择一个最能描述他们在过去 24 小时内最严重的关节疼痛的数字来评估他们的关节疼痛，其中 0 代表“没有疼痛”，10 代表“你能想象到的疼痛程度”。 参与者在每日电子日记中报告了他们最严重的关节疼痛。 计算每次就诊前 7 天的平均值。 关节疼痛严重程度等级的降低表明参与者的状况有所改善。
第 12 周
达到美国风湿病学会 50% (ACR50) 响应的参与者百分比
大体时间：第 12 周、第 24 周

ACR50 反应指数是 RA 临床、实验室和功能指标的综合。 “ACR50 响应者”是指在压痛和肿胀关节计数方面至少有 50% 的改善并且符合以下 5 项标准中的至少 3 项的参与者：

医生对疾病活动的整体评估、患者对疾病活动的整体评估、HAQ-DI、关节炎引起的疼痛和 hsCRP。 缺少反应的参与者和停止研究或药物或在分析时间点之前获救的参与者被视为无反应者。
第 12 周、第 24 周
达到美国风湿病学会 70% (ACR70) 响应的参与者百分比
大体时间：第 12 周、第 24 周
ACR70 反应指数是 RA 临床、实验室和功能指标的综合。 “ACR70 响应者”是指在压痛和肿胀关节计数方面至少有 70% 改善并且符合以下 5 项标准中的至少 3 项的参与者：医生对疾病活动的全面评估、患者对疾病活动的全面评估、HAQ-DI、关节炎引起的疼痛和 hsCRP。 缺少反应的参与者和停止研究或药物或在分析时间点之前获救的参与者被视为无反应者。
第 12 周、第 24 周
临床疾病活动指数 (CDAI) 评分测量的基线变化
大体时间：基线，第 24 周
• CDAI 是一种用于测量 RA 疾病活动的工具，不需要实验室组件，并由研究中心进行评分。 它整合了 TJC28（得分 0-28，得分越高表明疾病活动度越高）、SJC28（得分 0-28，得分越高表明疾病活动度越高）、患者疾病活动度的整体评估（在 0-10 厘米的视觉模拟量表上得分）分数越高表明疾病活动性越高），以及医生对疾病活动性的整体评估（在 0-10 厘米的视觉模拟量表上评分，分数越高表明疾病活动性越高）。 CDAI 是通过将 4 个分量的值相加来计算的。 CDAI分数范围从0到76；较低的分数表示较低的疾病活动。 与基线相比的负变化表明状况有所改善。
基线，第 24 周
简化疾病活动指数 (SDAI) 评分测量的基线变化
大体时间：基线，第 24 周
SDAI 是一种用于测量 RA 疾病活动的工具，它整合了 TJC28、SJC28、使用 C 反应蛋白（毫克/升）的急性期反应、使用视觉模拟量表 (cm) 的患者对疾病活动的整体评估以及医生的整体评估使用视觉模拟量表 (cm) 的疾病活动度。 SDAI 是通过将 5 个分量的值相加计算得出的。 较低的分数表示较少的疾病活动。 SDAI 表示为最低分数 = 0（最好）到最高分数 = 86（最差）的分数。 相对于基线的负变化表示改进。
基线，第 24 周
DAS28-红细胞沉降率 (DAS28-ESR) 相对于基线的变化
大体时间：基线，第 12 周
DAS28 由以下变量的综合评分组成：压痛关节计数 (TJC28)、肿胀关节计数 (SJC28)、红细胞沉降率 (ESR)（毫米/小时）和患者的疾病活动总体评估。 使用以下公式计算 DAS28：DAS28-ESR=0.56*square 根 (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*自然 log(ESR)+0.014*患者的 全球增值服务。 分数范围为 1.0-9.4， 其中较低的分数表示较少的疾病活动。
基线，第 12 周
达到美国风湿病学会欧洲抗风湿病联盟 (ACR/EULAR) 缓解的参与者百分比 - 布尔缓解
大体时间：第 12 周
RA 缓解的 ACR/EULAR 定义包括基于布尔的定义。 当在同一次就诊时满足以下所有 4 个标准时，即出现基于布尔值的缓解定义：TJC28 ≤1，SJC28 ≤1，使用 C 反应蛋白（毫克/分升）的急性期反应≤1，患者对使用 VAS 的疾病活动度 (cm) ≤1。
第 12 周
慢性疾病治疗疲劳功能评估 (FACIT-F) 评分相对于基线的变化。
大体时间：基线，第 12 周；基线第 24 周
慢性疾病治疗-疲劳功能评估 (FACIT-F) 量表是一份简短的 13 项针对特定症状的问卷，专门评估参与者自我报告的疲劳严重程度及其对日常活动和功能的影响。 FACIT-F 对每个项目使用 0（“完全没有”）到 4（“非常多”）的数字评分量表来评估过去 7 天的疲劳及其影响。 总分范围从 0 到 52，分数越高表明疲劳程度越低。
基线，第 12 周；基线第 24 周
医疗结果研究 36 项简短健康调查第 2 版（SF-36v2 急性）的心理成分评分 (MCS)、身体成分评分 (PCS) 相对于基线的变化
大体时间：基线，第 12 周；基线，第 24 周
SF-36 是一项评估参与者生活质量的健康相关调查，由 36 个问题组成，涵盖 8 个健康领域：身体机能、身体疼痛、身体问题和情绪问题导致的角色限制、一般健康、心理健康、社会功能、活力和 2 个组成部分分数（心理 [MCS] 和身体 [PCS]）。 MCS 包括社会功能、活力、心理健康和角色情绪量表。 PCS 包括身体机能、身体疼痛、身体角色和一般健康量表。 每个领域的评分是通过将各个项目相加并将分数转换为 0 到 100 的等级，分数越高表示健康状况或功能越好。
基线，第 12 周；基线，第 24 周
欧洲生活质量基线的变化 - 5 个维度 - 5 个级别 (EQ-5D-5L) 分数
大体时间：基线第 12 周；基线第 24 周
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) 是衡量参与者健康状况的标准化指标。 其中一个组成部分包括一个描述受访者健康状况的系统，该系统由以下 5 个参与者报告的维度组成：行动能力、自我保健、日常活动、疼痛/不适和焦虑/抑郁。 每个维度有5个等级：没有问题、轻微问题、中度问题、严重问题和极端问题。 这些回答用于使用英国 (UK) 算法和美国 (US) 算法得出健康状况指数得分，得分范围为 -0.594 至 1，得分范围为 -0.109 至 1。 分数越高表明健康状况越好。
基线第 12 周；基线第 24 周
欧洲生活质量基线的变化 - 5 个维度 - 5 级 (EQ-5D-5L) 分数（自我感知健康）
大体时间：基线第 12 周；基线第 24 周
EQ-5D-5L 的第二个组成部分是自我感知的健康评分，使用范围为 0 到 100 毫米 (mm) 的 VAS 进行评估，其中 0 表示您可以想象的最差健康状况，100 表示您认为最好的健康状况可以想象。
基线第 12 周；基线第 24 周
工作效率和活动障碍-类风湿性关节炎 (WPAI-RA) 评分相对于基线的变化
大体时间：基线，第 12 周；基线，第 24 周
开发了工作效率和活动障碍-类风湿性关节炎 (WPAI-RA) 调查问卷，以测量就诊前 7 天总体健康状况和症状严重程度对工作效率和常规活动的影响。 它包含 6 个项目，涵盖整体工作效率（健康）、整体工作效率（症状）、日常活动障碍（健康）和日常活动障碍（症状）。 分数按减值百分比计算。 WPAI-RA 产生四种类型的分数：旷工（错过工作时间）、出勤率（工作受损）、工作效率损失（整体工作受损）和活动受损。
基线，第 12 周；基线，第 24 周
群体药代动力学 (PK)：LY3009104 在稳态给药时的最大浓度 (Cmax,ss)
大体时间：第 0 周：给药后 30 和 90 分钟；第 8 周：给药后 1 小时；第 12 周、第 20 周和第 24 周：给药前
第 0 周：给药后 30 和 90 分钟；第 8 周：给药后 1 小时；第 12 周、第 20 周和第 24 周：给药前
群体 PK：LY3009104 在稳态给药时的最大浓度 (AUC,ss)
大体时间：第 0 周：给药后 30 和 90 分钟；第 8 周：给药后 1 小时；第 12 周、第 20 周和第 24 周；给药前
第 0 周：给药后 30 和 90 分钟；第 8 周：给药后 1 小时；第 12 周、第 20 周和第 24 周；给药前

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

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。

一般刊物

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

2012年12月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2012年11月1日

首先提交符合 QC 标准的

2012年11月1日

首次发布 (估计)

2012年11月2日

研究记录更新

最后更新发布 (实际的)

2019年9月18日

上次提交的符合 QC 标准的更新

2019年9月9日

最后验证

2019年9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

  • 14059
  • I4V-MC-JADX (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

研究计划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

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.

安慰剂的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Albania

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅