登记号
CTR20223121
相关登记号
曾用名
药物类型
生物制品
临床申请受理号
企业选择不公示
适应症
类风湿关节炎
试验通俗题目
一项在中重度活动性类风湿关节炎成人受试者中评价peresolimab的2b期研究
试验专业题目
一项在中重度活动性类风湿关节炎成人受试者中评价peresolimab的2b期、双盲、安慰剂对照研究
试验方案编号
J1A-MC-KDAF
方案最近版本号
e
版本日期
2023-05-31
方案是否为联合用药
否
申请人信息
申请人名称
联系人姓名
朱彤
联系人座机
021-23021370
联系人手机号
15021603639
联系人Email
zhu_tong@lilly.com
联系人邮政地址
上海市-上海市-静安区石门一路288号太古汇一座19层
联系人邮编
200041
临床试验信息
试验分类
安全性和有效性
试验分期
II期
试验目的
根据达到ACR20的受试者比例，评价peresolimab与安慰剂相比的有效性
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
18岁(最小年龄)至
无上限
(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 签署知情同意时受试者年龄≥18岁。
- 根据2010 年美国风湿病学会（ACR）/欧洲抗风湿病联盟（EULAR）分类标准的定义，在筛选前≥3个月确诊为RA的成人患者。
- 筛选和基线时存在中重度活动性RA。
- 对至少一种传统合成DMARD(csDMARD)或生物制剂DMARD（bDMARD）或靶向合成DMARD(tsDMARD)应答不佳或失应答或不耐受。
排除标准
- 根据ACR标准，存在IV类RA。
- 根据研究者的判断，存在一种或多种重大合并症，包括但不限于： 控制不佳的糖尿病或高血压 慢性肾脏病 IIIb 期、IV 期或 V 期 纽约心脏协会 II 级、III 级或 IV 级症状性心力衰竭 随机化前 12 个月内发生过心肌梗死、不稳定型心绞痛、卒中或短暂性脑缺血发作 重度慢性肺病，例如，需要氧疗 除 RA 外的重大慢性炎症性疾病或结缔组织疾病，包括但不限于： o 系统性红斑狼疮 o 银屑病关节炎 o 中轴型脊柱关节炎 o 反应性关节炎 o 痛风 o 硬皮病 o 多发性肌炎 o 皮肌炎 o 活动性纤维肌痛，或 o 多发性硬化。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:无
|
剂型:注射剂
|
|
中文通用名:无
|
剂型:注射剂
|
|
中文通用名:无
|
剂型:注射剂
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂
|
剂型:注射剂
|
|
中文通用名:安慰剂
|
剂型:注射剂
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 第12周达到ACR20的受试者比例 | 第12周 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 评价peresolimab与安慰剂相比对疾病活动指标的影响 | 第12周 | 有效性指标 |
| 评价peresolimab与安慰剂相比对患者报告结局指标的影响 | 第12周 | 有效性指标 |
| 评价peresolimab对疾病活动指标的影响 | 第12周 | 有效性指标 |
| 确定peresolimab的药代动力学特征 | 第12周 | 有效性指标+安全性指标 |
数据安全监察委员会（DMC）
无
为受试者购买试验伤害保险
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 邹和建 | 医学博士 | 主任医师 | 13311881366 | mail@hjzou.com | 上海市-上海市-乌鲁木齐中路12号 | 200040 | 复旦大学附属华山医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 复旦大学附属华山医院 | 邹和建 | 中国 | 上海市 | 上海市 |
| 蚌埠医学院第一附属医院 | 李志军 | 中国 | 安徽省 | 蚌埠市 |
| 四川大学华西医院 | 赵毅 | 中国 | 四川省 | 成都市 |
| 中南大学湘雅医院 | 李通 | 中国 | 湖南省 | 长沙市 |
| 深圳市人民医院 | 刘冬舟 | 中国 | 广东省 | 深圳市 |
| 萍乡市人民医院 | 胡建康 | 中国 | 江西省 | 萍乡市 |
| 汕头大学医学院第一附属医院 | 侯志铎 | 中国 | 广东省 | 汕头市 |
| 中山大学附属第一医院 | 杨念生 | 中国 | 广东省 | 广州市 |
| 北京大学人民医院 | 周云杉 | 中国 | 北京市 | 北京市 |
| 华中科技大学同济医学院附属同济医院 | 董凌莉 | 中国 | 湖北省 | 武汉市 |
| CIPREC Sede Arenales Loc. 60 | Guillermo Bartel | Argentina | Ciudad Autónoma de Buenos Aires | Buenos Aires |
| Organizacion Medica de Investigacion Loc. 9 | Eduardo Mysler | Argentina | Buenos Aires | CABA |
| CER San Juan Loc. 30 | Rodolfo Pardo Hidalgo | Argentina | San Juan | San Juan |
| Centro Privado de Medicina Familiar / Mindout Research Loc. 17 | Leonardo Naftal | Argentina | Buenos Aires | Ciudad Autónoma de Buenos Aires |
| Centro Medico Privado de Reumatologia Loc. 17 | Walter Spindler | Argentina | Tucumán | SAN M. DE TUCUMAN |
| Instituto Medico Strusberg Loc. 19 | Marcos Baravalle | Argentina | Córdoba | Córdoba |
| APRILLUS Asistencia E Investigacion Loc. 19 | Pablo Mannucci Walter | Argentina | Buenos Aires | CABA |
| Centro de Enfermedades de Hígado y Aparato Digestivo Loc. 3 | Judith Carrio | Argentina | Santa Fe | Rosario |
| Clinica Adventista Belgrano Loc. 18 | Federico Ariel | Argentina | Buenos Aires | CABA |
| Fundación Respirar Loc. 54 | ALEJANDRO ARROYO | Argentina | Buenos Aires | Buenos Aires |
| Hospital Córdoba | Veronica Savio | Argentina | Córdoba | Córdoba |
| Centre de Recherche Musculo-Squelettique | Frederic Morin | Canada | Quebec | Trois-Rivières |
| Aggarwal and Associates Limited | Naresh Aggarwal | Canada | Ontario | brampton |
| G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. | Louis Bessette | Canada | Quebec | Quebec |
| Clinic of Rheumatology and Clinical Immunology Loc. 1 | Prodromos Sidiropoulos | Greece | Krítí | Heraklion |
| 2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit Loc. 1 | Dimitrios Vassilopoulos | Greece | Attikí | Athens |
| First Department of Internal Medicine Loc. 1 | Charalampos Papagoras | Greece | évros | ALEXANROUPOLIS |
| 4th Department of Medicine/ Rheumatology and Immunology Unit Loc. 1 | Dimitrios Boumpas | Greece | Attikí | Chaidari |
| 1st Department of Propaedeutic Internal Medicine Loc. 1 | PETROS SFIKAKIS | Greece | Attikí | Athens |
| Qualiclinic | Istvan Szombati | Hungary | Budapest | Budapest |
| Revita Clinic | Regina Cseuz | Hungary | Pest | Budapest |
| Vital Medical Center | Edit Drescher | Hungary | Veszprém City | Veszprem |
| Reumatologia Loc. 1 | Serena Guiducci | Italy | Firenze | Firenze |
| U.O. Reumatologia Loc. 1 | PIERCARLO SARZI PUTTINI | Italy | Milano | Milan |
| UOC Reumatologia Loc. 1 | Ombretta Viapiana | Italy | Verona | Verona |
| Koujunkai Daido Clinic Loc. 3 | Yoichiro Haji | Japan | Aichi | Nagoya |
| Chubu Rosai Hospital | Yoshiro Fujita | Japan | Aichi | Nagoya |
| University of Occupational and Enviromental Health | Shingo Nakayamada | Japan | Fukuoka | Kitakyushu |
| Machida Municipal Hospital | Megumi Hiida | Japan | Tokyo | Tokyo |
| Tobata General Hospital | Kazuyoshi Saito | Japan | Fukuoka | Kitakyushu |
| Hiroshima University Hospital | Shintaro Hirata | Japan | Hiroshima | Hiroshima |
| Yoshida Internal Medicine Clinic | Tomohiko Yoshida | Japan | Nagano | Sakaki |
| Bayside Misato Medical Center | Yoshinori Taniguchi | Japan | Kochi | Kochi |
| Tonan Hospital | Kazuaki Katsumata | Japan | Hokkaido | Sapporo |
| Sagawa Akira Rheumatology Clinic Loc. 3 | AKIRA FURUSAKI | Japan | Hokkaido | Sapporo |
| Juntendo University Hospital | Michihiro Ogasawara | Japan | Tokyo | Bunkyo-ku |
| Okayama City General Medical Center Okayama City Hospital | Hiroshi Wakabayashi | Japan | Okayama | Okayama |
| Hirose Clinic - Tokorozawa | Wataru Hirose | Japan | Saitama | Tokorozawa |
| Sasebo Chuo Hospital | Yukitaka Ueki | Japan | Nagasaki | Sasebo |
| Shinkokura Hospital | Hiroshi Tsukamoto | Japan | Fukuoka | Kitakyushu |
| Hiroshima Clinic | KEISUKE ODA | Japan | Hiroshima | Hiroshima |
| Clinica de Investigacion en Reumatologia y Obesidad S. C. | Sergio Duran-Barragan | Mexico | Jalisco | Guadalajara |
| Kohler and Milstein Research S.A. de C.V. Loc. 1 | Jesus Simon Campos | Mexico | Yucatán | Mérida |
| Clinstile, S.A. de C.V. Loc. 7 | Favio Edmundo Enriquez Sosa | Mexico | Distrito Federal | Mexico |
| Centro Medico del Angel Loc. 6 | Beatriz Zazueta Montiel | Mexico | Baja California | Mexicali |
| Investigacion y Biomedicina de Chihuahua | Cesar Pacheco-Tena | Mexico | Chihuahua | Chihuahua |
| Rheuma Medicus Zaklad Opieki Zdrowotnej | Maria Rell-Bakalarska | Poland | Mazowieckie | Warszawa |
| Ambulatorium Sp. z o.o. Loc. 7 | Anna Bazela-Ostromecka | Poland | Warmińsko-mazurskie | Elblag |
| Nova Reuma Spolka Partnerska | Izabela Domyslawska | Poland | Podlaskie | Bialystok |
| Twoja Przychodnia NCM Loc. 2 | Malgorzata Miakisz | Poland | Lubuskie | Nowa Sol |
| Centrum Medyczne Reuma Park | Janusz Jaworski | Poland | Mazowieckie | Warszawa |
| MICS Centrum Medyczne Warszawa Loc. 6 | Katarzyna Romanowska - Prochnicka | Poland | Mazowieckie | Warszawa |
| Klinika Reumatologii i Ukladowych Chorob Tkanki cznej Loc. 1 | Rafal Wojciechowski | Poland | Kujawsko-pomorskie | Bydgoszcz |
| NZOZ BIF-MED | Hanna Mastalerz | Poland | Slaskie | Bytom |
| ai centrum medyczne sp. z o.o. sp.k. | Anna Rychlewska-Hanczewska | Poland | Wielkopolskie | Poznan |
| Twoja Przychodnia Poznanskie Centrum Medyczne | Agata Wytyk-Nowak | Poland | Wielkopolskie | Poznań |
| Rheumatology Loc. 1 | Maria Luz Garcia Vivar | Spain | País Vasco | Bilbo |
| Unidad de investigacion de Reumatologia Loc. 1 | JUAN SANCHEZ BURSON | Spain | Sevilla | Sevilla |
| CHUAC-Complejo Hospitalario Universitario A Coruna | Francisco Javier Blanco Garcia | Spain | A Coruna | A Coruna |
| Hospital Universitario Marqués de Valdecilla | Ricardo Blanco | Spain | Cantabria | Santander |
| Clínica Gaias - Santiago | Juan Gomez-Reino | Spain | A Coruna | Santiago de Compostela |
| Clinical Trial Unit - Rheumatalogy department Loc. 1 | Antonio Mera Varela | Spain | Galicia [Galicia] | Santiago de Compostela |
| Albuquerque Clinical Trials, Inc. Loc. 4 | Satkirin Khalsa | United States | New Mexico | Albuquerque |
| Physician Research Collaboration, LLC Loc. 4 | Melvin Churchill | United States | Nebraska | Lincoln |
| Latin Clinical Trial Center Loc. 8 | Carlos Pantojas | United States | Puerto Rico | San Juan |
| Medvin Clinical Research - Metyas Loc. 4 | Samy Metyas | United States | California | Covina |
| East Bay Rheumatology Medical Group, Inc Loc. 7 | Suneet Grewal | United States | California | San Leandro |
| Desert Medical Advances Loc. 6 | Maria Greenwald | United States | California | Palm Desert |
| Paramount Medical Research & Consulting, LLC Loc. 3 | Isam Diab | United States | Ohio | Middleburg Heights |
| Accurate Clinical Management - Houston Loc. 4 | Amber Khan | United States | Texas | Houston |
| Medvin Clinical Research - Su Loc. 1 | Tien-I Su | United States | California | Whittier |
| Mindful Medical Research Loc. 4 | Oscar Soto-Raices | United States | Puerto Rico | San Juan |
| Saint Louis Rheumatology Loc. 1 | Chad Ronholm | United States | Missouri | St. Louis |
| Rheumatology Loc. 1 | AMARILIS PEREZ DE JESUS | United States | Puerto Rico | caguas |
| Denver Arthritis Clinic Loc. 5 | Christopher Antolini | United States | Colorado | Denver |
| Arizona Arthritis & Rheumatology Research, PLLC Loc. 9 | Swati Bharadwaj | United States | Arizona | Mesa |
| Accurate Clinical Research Loc. 14 | Philip Waller | United States | Texas | Houston |
| DM Clinical Research Loc. 5 | Shaikh Ali | United States | Texas | Tomball |
| Arthritis Consultants, Inc. Loc. 6 | Akgun Ince | United States | Missouri | Saint Louis |
| Piedmont Arthritis Clinic Loc. 2 | Jeffrey Lawson | United States | South Carolina | Greenville |
| Arizona Arthritis & Rheumatology Research, PLLC Loc. 9 | Nehad Soloman | United States | Arizona | Phoenix |
| Research Loc. 7 | Leroy Pacheco | United States | New Mexico | Albuquerque |
| Great Lakes Clinical Trials - Ravenswood Loc. 1 | Manish Jain | United States | Illinois | Chicago |
| Clinical Research of West Florida Loc. 2 | Priya Reddy, MD | United States | Florida | Tampa |
| AA Medical Research Center Loc. 3 | ALI KARRAR | United States | Michigan | Grand Blanc |
| Rheumatology & Pulmonary Clinic Loc. 2 | Wassim Saikali | United States | West Virginia | Beckley |
| Encore Medical Research of Boynton Beach Loc. 1 | Jude Acloque | United States | Florida | Boynton Beach |
| Advanced Rheumatology, PC Loc. 3 | Monika Mohan | United States | Michigan | Lansing |
| Arthritis & Osteoporosis Associates - Freehold Loc. 3 | Hisham El-Kadi | United States | New Jersey | Freehold |
| DJL Clinical Research, PLLC Loc. 5 | Emily Box | United States | North Carolina | Charlotte |
| Tekton Research, Inc Loc. 3 | Paul Pickrell | United States | Texas | Austin |
| Clinical Research Loc. 3 | David Snow | United States | North Carolina | Leland |
| Accurate Clinical Management Loc. 2 | Sabeen Najam | United States | Texas | Baytown |
| DM Clinical Research/Rheumatology Clinic of Houston Loc. 3 | Qaisar Rehman | United States | Texas | Tomball |
| ForCare Clinical Research Loc. 3 | Tanya Bogle | United States | Florida | Tampa |
| Accurate Clinical Research Loc. 13 | Enrique Mendez | United States | Louisiana | Lake Charles |
| Great Lakes Research Group, Inc. Loc. 10 | Jeffrey Potts | United States | Michigan | Bay City |
| NYU Langone Ambulatory Care Brooklyn Heights Loc. 1 | David Goddard | United States | New York | Brooklyn |
| West Virginia Research Institute Loc. 4 | Suzanne Gharib | United States | West Virginia | South Charleston |
| Dan La, MD Inc Loc. 2 | DAN LA | United States | California | Tujunga |
| Primary Care & Rheumatology TAMPA Loc. 1 | Michael Burnette | United States | Florida | Tampa |
| BMG Rheumatology Suncoast Loc. 1 | Sonialy Lugo-Ruiz | United States | Florida | St. Petersburg |
| Arizona Arthritis & Rheumatology Research PLLC Loc. 4 | Joonhee Lim | United States | Arizona | Gilbert |
| Accel Research Sites – Birmingham Clinical Research Unit Loc. 1 | Hayes Williams | United States | Alabama | Birmingham |
| Health Research of Oklahoma Loc. 5 | Christine Codding | United States | Oklahoma | Oklahoma City |
| HARAC Research Corp Loc. 1 | Alexander Torres | United States | Florida | Avon Park |
| Clinical Research of West Florida, Inc. (Clearwater) Loc. 3 | Rodney Daniel | United States | Florida | Clearwater |
| Arizona Arthritis & Rheumatology Research, PLLC Loc. 8 | Mona Amin | United States | Arizona | Glendale |
| GCM Medical Group, PSC - Hato Rey Site Loc. 6 | Karina Vila-Rivera | United States | Puerto Rico | San Juan |
| West Broward Rheumatology Associates Loc. 2 | Elias Halpert | United States | Florida | Tamarac |
| Sound Clinical Research, LLC Loc. 2 | Jeff Peterson | United States | Washington | Bothell |
| Wolverine Clinical Trials Loc. 1 | Behnam Khaleghi | United States | California | Santa Ana |
| Clinvest Research LLC | David True | United States | Missouri | Springfield |
| Newport Huntington Medical Group Loc. 1 | Christine Thai | United States | California | Huntington Beach |
| altoona center for clinical research Loc. 4 | Alan Kivitz | United States | Pennsylvania | Duncansville |
| Arthritis and Rheumatology Center of MI - Rochester Hills Loc. 1 | Srijana Pradhan Bakshi | United States | Michigan | Rochester Hills |
| Rheumatology Loc. 1 | Shirley Pang | United States | California | Fullerton |
| Research Loc. 7 | Christopher Wright | United States | Washington | Spokane |
| Suncoast Clinical Research, Inc. | Farrukh Zaidi | United States | Florida | New Port Richey |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 复旦大学附属华山医院伦理审查委员会 | 同意 | 2022-11-02 |
| 复旦大学附属华山医院伦理审查委员会 | 同意 | 2022-12-16 |
| 复旦大学附属华山医院伦理审查委员会 | 同意 | 2023-03-08 |
| 复旦大学附属华山医院伦理审查委员会 | 同意 | 2023-05-05 |
| 复旦大学附属华山医院伦理审查委员会 | 同意 | 2023-06-21 |
试验状态信息
试验状态
主动终止
目标入组人数
国内: 28 ；
国际: 420 ；
已入组例数
国内: 25 ；
国际: 491 ；
实际入组总例数
国内: 25 ；
国际: 491 ；
第一例受试者签署知情同意书日期
国内：2023-02-16；
国际：2022-08-31；
第一例受试者入组日期
国内：2023-04-28；
国际：2022-11-14；
试验终止日期
国内：2024-09-20；
国际：2024-09-20；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
