北京艾加莫德α注射液（皮下注射）III期临床试验-评价Efgartigimod PH20 SC在原发性干燥综合征患者中的有效性、安全性和耐受性的研究

登记号	CTR20252164	试验状态	进行中
申请人联系人	何燕	首次公示信息日期	2025-06-03
申请人名称	argenx BV/ 再鼎医药（上海）有限公司/ Vetter Pharma-Fertigung GmbH & Co. KG

登记号	CTR20252164
相关登记号	暂无
药物名称	艾加莫德α注射液（皮下注射）
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	原发性干燥综合征
试验专业题目	一项在成人原发性干燥综合征受试者中评价预充式注射器皮下给与Efgartigimod PH20 的有效性、安全性和耐受性的III 期、随机、双盲、安慰剂对照、多中心研究接开放标签扩展研究
试验通俗题目	评价Efgartigimod PH20 SC在原发性干燥综合征患者中的有效性、安全性和耐受性的研究
试验方案编号	ARGX-113-2306	方案最新版本号	2.0
版本日期:	2024-09-27	方案是否为联合用药	否

申请人名称	[["argenx BV"],["再鼎医药（上海）有限公司"],["Vetter Pharma-Fertigung GmbH & Co. KG"]]
联系人姓名	何燕	联系人座机	021-61632588	联系人手机号	13564564887
联系人Email	Sandy.he@zailaboratory.com	联系人邮政地址	上海市-上海市-上海浦东新区张江高科技园区金科路4560号金创大厦1号楼4楼	联系人邮编	201210

通过clinESSDAI 比较Efgartigimod PH20 SC 与安慰剂的系统疾病活动度评价有效性

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

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	[["签署知情同意书（ICF）时年龄至少为18 岁"],["筛选时满足以下标准：n- 2016 年ACR/EULAR pSjD 分类标准n- clinESSDAI ≥ 6n- 中心实验室检测anti-Ro/SS-A 阳性n- 未刺激残存唾流率（≥ 0.01 mL/min）"]]
排除标准	[["除研究疾病外，具有会干扰pSjD 临床症状的准确评估或使患者处于过度风险中的任何其他已知自身免疫性疾病或医学状况"],["其他已确认的自身免疫病（例如类风湿关节炎，系统性红斑狼疮，硬皮病和炎性肠病）为主要诊断的继发性干燥综合征"],["经研究者评估，基线时存在可能使患者处于过度风险中的控制不佳的严重系统性pSjD 表现。包括pSjD 相关的CTCAE≥2 级的血细胞减少"],["筛选期受试者患有重度肾功能损害（估算肾小球滤过率<30 mL/min/1.73 m2）"],["恶性肿瘤病史，除非通过充分治疗认为已治愈，且在IMP 首次给药前≥ 3 年内无复发。"],["存在基线时仍未完全缓解的重度或严重活动性感染或使受试者处于不必要风险的活动性感染或研究者认为会混淆研究结果感染"],["筛选时活动性病毒感染的血清检测结果呈阳性"],["存在具有临床意义的疾病或研究者认为可能混淆研究结果或使受试者处于过度风险的任何其他情况。近期接受过大手术（筛选前≤3 个月）或在研究期间打算进行手术"],["研究者评估的受试者现有或既往（筛选前≤12 个月）有酒精、毒品或药物滥用史。禁止娱乐性或处方使用大麻或大麻酚"],["受试者妊娠或处于哺乳期，或计划在研究期间怀孕"],["筛选期总IgG<4 g/L"],["皮质类固醇：na. 筛选前<8 周开始的系统性皮质类固醇治疗，或筛选前≥4 周未稳定接受≤7.5mg 泼尼松或等效剂量或筛选期间调整剂量。"],["接受以下任何一种治疗：n- 下述允许的DMARDs 药物以外的DMARD：羟氯喹、氯喹、奎纳克林、甲氨蝶呤、吗替麦考酚酯、霉酚酸酯、硫唑嘌呤、柳氮磺胺吡啶、咪唑立宾、来氟米特、他克莫司和环孢素。"],["同时参与其他干预性临床研究"],["在筛选前<12 周或<5 个半衰期（以较长者为准）内使用其他IMP"],["已知对IMP 或任一辅料存在超敏反应"],["受试者既往参加过Efgartigimod 临床研究，并接受过至少1 次IMP 给药"]]

试验药	[["中文通用名:艾加莫德α注射液（皮下注射） 英文通用名:EfgartigimodAlfaInjection(SubcutaneousInjection)/EfgartigimodPH20SC 商品名称:NA","剂型:注射剂 规格:5ml/支 用法用量:皮下注射，每次一支 用药时程:第1天至第47周为双盲阶段；第48至96周为开放标签阶段"]] 序号 名称 用法
对照药	[["中文通用名:匹配的安慰剂 英文通用名:Placebo 商品名称:NA","剂型:注射剂 规格:5mL/支 用法用量:皮下注射，每次一支 用药时程:第1天至第47周为双盲阶段"]] 序号 名称 用法

主要终点指标及评价时间	[["48 周时clinESSDAI 较基线的变化","长达48周","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["48 周时ESSDAI 较基线的变化","长达48周","有效性指标"],["48 周时达到低疾病活动度（clinESSDAI<5）的受试者比例","长达48周","有效性指标"],["48 周时达到STAR 应答（定义为≥5 分）的受试者比例","长达48周","有效性指标"],["48 周时DiSSA 关节疼痛项目较基线的变化","长达48周","有效性指标"],["48 周时DiSSA 总分较基线的变化","长达48周","有效性指标"],["48 周时DiSSA 干燥项目较基线的变化","长达48周","有效性指标"],["48 周时ESSDAI 评分达到MCII （定义为改善≥3 分）的受试者比例","长达48周","有效性指标"],["24 周时clinESSDAI 较基线的变化","长达24周","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	曾小峰	学位	医学博士	职称	主任医师
	电话	13501069845	Email	zengxfpumc@163.com	邮政地址	北京市-北京市-北京市东城区帅府园一号
	邮编	100730	单位名称	中国医学科学院北京协和医院

[["中国医学科学院北京协和医院","曾小峰","中国","北京市","北京市"],["北京大学人民医院","何菁","中国","北京市","北京市"],["北京大学第三医院","穆荣","中国","北京市","北京市"],["西安交通大学第一附属医院","何岚","中国","陕西省","西安市"],["临沂市人民医院","厉彦山","中国","山东省","临沂市"],["浙江省人民医院","李涯松","中国","浙江省","杭州市"],["上海交通大学医学院附属仁济医院","李挺","中国","上海市","上海市"],["复旦大学附属华山医院","孔宁","中国","上海市","上海市"],["南昌大学第一附属医院","吴锐","中国","江西省","南昌市"],["赣州市人民医院","李东升","中国","江西省","赣州市"],["中山大学附属第三医院","潘云峰","中国","广东省","广州市"],["中山大学孙逸仙纪念医院","莫颖倩","中国","广东省","广州市"],["四川省人民医院","朱静","中国","四川省","成都市"],["昆明医科大学第一附属医院","徐建","中国","云南省","昆明市"],["济宁医学院附属医院","宋芹","中国","山东省","济宁市"],["济宁市第一人民医院","李树杰","中国","山东省","济宁市"],["临汾市中心医院","强树华","中国","山西省","临汾市"],["新乡市中心医院","范文强","中国","河南省","新乡市"],["安徽省立医院","厉小梅","中国","安徽省","合肥市"],["南方医科大学珠江医院","接力刚","中国","广东省","广州市"],["南京大学医学院附属鼓楼医院","孙凌云","中国","江苏省","南京市"],["萍乡市人民医院","何德宁","中国","江西省","萍乡市"],["河北医科大学第二医院","郭惠芳","中国","河北省","石家庄市"],["大连医科大学第二附属医院","孔晓丹","中国","辽宁省","大连市"],["山西白求恩医院","张莉芸","中国","山西省","太原市"],["温州医科大学附属第一医院","孙莉","中国","浙江省","温州市"],["蚌埠医科大学第一附属医院","谢长好","中国","安徽省","蚌埠市"],["郑州大学第一附属医院","刘升云","中国","河南省","郑州市"],["川北医学院附属医院","袁国华","中国","四川省","南充市"],["广西医科大学第一附属医院","莫汉有","中国","广西壮族自治区","南宁市"],["贵州医科大学附属医院","曾家顺","中国","贵州省","贵阳市"],["淮安市第一人民医院","孟德钎","中国","江苏省","淮安市"],["北京大学第一医院","张卓莉","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"],["河南科技大学第一附属医院","史晓飞","中国","河南省","洛阳市"],["Centro Medico Arsema","Ariel, Federico Javier","阿根廷","Buenos Aires","CABA"],["Centro de Investigaciones Medicas Tucuman","Berman, Horacio","阿根廷","Tucuman","San Miguel de Tucuman"],["Consultorios Reumatologicos Pampa","Correa, Maria de los Angeles","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["Hospital Britanico de Buenos Aires","Duartes Noe, Damian","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["Centro de Investigaciones Reumatológicas","Gonzalez Lucero, Luciana","阿根廷","Tucuman","San Miguel de Tucuman"],["Centro de Investigaciones Medicas Mar del Plata","Iturralde, Carolina","阿根廷","Buenos Aires","Mar del Plata"],["APRILLUS Asistencia e Investigacion","Mannucci Walter, Pablo Alejandro","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Sanatorio Parque S.A.","Pons Estel, Bernardo Antonio","阿根廷","Santa Fe","Rosario"],["Centro Medico Barrio Parque","Secco, Anastasia","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Instituto de Investigaciones Clinicas Quilmes","Velasco Zamora, Jose Luis","阿根廷","Buenos Aires","Quilmes"],["Instituto CAICI","Viola, Diego Oscar","阿根廷","Santa Fe","Rosario"],["Monash Medical Centre Clayton","Hoi, Alberta","阿根廷","Victoria","Clayton"],["Fiona Stanley Hospital","Keen, Helen","阿根廷","Western Australia","Murdoch"],["Royal Brisbane and Women's Hospital","Kubler, Paul","阿根廷","Queensland","Herston"],["The Queen Elizabeth Hospital.","Rischmueller, Maureen","阿根廷","South Australia","Woodville South"],["Westmead Hospital","Swaminathan, Sanjay","阿根廷","New South Wales","Sydney"],["Royal Prince Alfred Hospital Australia","Youssef, Peter","阿根廷","New South Wales","Camperdown"],["Rheuma-Zentrum Wien Oberlaa","Spellitz, Peter","奥地利","Wien","Wien"],["UZ Leuven","De Langhe, Ellen","比利时","Leuven","Leuven"],["HUB Erasme","Margaux, Joelle","比利时","Bruxelles","Bruxelles"],["UZ Gent","Peene, Isabelle","比利时","Gent","Gent"],["UZA","Van Mechelen, Margot","比利时","Edegem","Edegem"],["ReumaClinic","Vanhoof, Johan","比利时","Genk","Genk"],["MHAT Dr Ivan Seliminski AD","Ganchev, Todor","比利时","Sliven","Sliven"],["MC Artmed OOD","Geneva-Popova, Mariela","比利时","Plovdiv","Plovdiv"],["DCCC","Ivanova, Delina","比利时","Sofia","Sofia"],["UMHAT “Pulmed” OOD","Sapoundziev, Lyubomir","比利时","Plovdiv","Plovdiv"],["CHUS - H？tel-Dieu","Allard-Chamard, Hugues","加拿大","Quebec","Sherbrooke"],["G.R.M.O Groupe De Recherche En Maladie Osseuses Inc","Desaulniers, Philippe","加拿大","Quebec","Quebec"],["Mary Pack Arthritis Centre","Mai, Alice","加拿大","British Columbia","Vancouver"],["Applied Medical Informatics Research Inc.","Tsoukas, Alexander","加拿大","Quebec","Montreal"],["Toronto Western Hospital","Wither, Joan","加拿大","Ontario","Toronto"],["Clinical Research Chile SpA.","Concha Mosqueira, Luis Eugenio","智利","Valdivia","Valdivia"],["CTR Estudios","Donaire, Luisa","智利","Santiago","Santiago"],["Centro Medico Prosalud","Goecke Sariego, Irmgadt Annelise","智利","Santiago","Santiago"],["Centro de Estudios Reumatologicos","Miranda Cabezas, Pedro Claudio","智利","Santiago","Santiago"],["BioMedica Research Group","Moreno Goio, Elizabeth Jean","智利","Santiago","Santiago"],["Enroll Spa","Roman, Carlos","智利","Santiago","Santiago"],["Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS","Abello Banfi, Mauricio Ricardo","哥伦比亚","Barranquilla","Barranquilla"],["Servicios De Salud IPS Suramericana S A S Chipichape IPS","Arbelaez Cortes, Alvaro","哥伦比亚","Cali","Cali"],["Sociedad de Cirugia de Bogota Hospital de San Jose","Arredondo, Ana Maria","哥伦比亚","Bogota","Bogota"],["BlueCare S.A.S","Chalem Choueka, Philippe Selim","哥伦比亚","Bogotá","Bogotá"],["Clinica de la Costa S.A.S","Godoy Martinez, Jesus Raimundo","哥伦比亚","Barranquilla","Barranquilla"],["Healthy Medical Center","Gomez Mora, Danny Alexis","哥伦比亚","Zipaquirá","Zipaquirá"],["IPS Centro Medico Julian Coronel S.A.","Izquierdo, Jorge Hernan","哥伦比亚","Cali","Cali"],["Centro de Investigacion Medico Asistencial S.A.S","Jaller Raad, Juan Jose","哥伦比亚","Barranquilla","Barranquilla"],["Preventive Care Ltda","Londono Patino, John Dario","哥伦比亚","Chia","Chia"],["Hospital Pablo Tobon Uribe","Marquez Hernandez, Javier Dario","哥伦比亚","Medellín","Medellín"],["Servicios De Salud IPS Suramericana S A S IPS Sura Industriales Medellin","Mesa Navas, Miguel Antonio","哥伦比亚","Medellin","Medellin"],["SERVIMED S.A.S.","Otero Escalante, William Jose","哥伦比亚","Bucaramanga","Bucaramanga"],["Fundacion Oftalmologica de Santander - FOSCAL","Saaibi Solano, Diego Luis","哥伦比亚","Floridablanca","Floridablanca"],["Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM","Velez Sanchez, Patricia Julieta","哥伦比亚","Bogotá","Bogotá"],["Oü Innomedica","Meisalu, Sandra","爱沙尼亚","Tallinn","Tallinn"],["Meditrials OU","Muller, Raili","爱沙尼亚","Tartu","Tartu"],["Center for Clinical and Basic Research","Valter, Ivo","爱沙尼亚","Tallinn","Tallinn"],["Hopital Edouard Herriot - CHU Lyon","Hot, Arnaud","法国","Rhone","Lyon cedex 3"],["CHR Orléans","Lespessailles, Eric","法国","Loiret","Orléans Cedex 2"],["H？pital Saint Joseph","Poulet, Antoine","法国","Bouches-du-Rh？ne","Marseille"],["Groupe Hospitalier Pitie-Salpetriere","Saadoun, David","法国","Paris","Paris cedex 13"],["H？pital Lariboisière","Sene, Damien","法国","Paris","Paris"],["First Medical Center","Kobakhidze, Tamta","格鲁吉亚","Tbilisi","Tbilisi"],["Innova LLC","Lagvilava, Luba","格鲁吉亚","Tbilisi","Tbilisi"],["MediClub Georgia","Lortkipanidze, Mamuka","格鲁吉亚","Tbilisi","Tbilisi"],["Clinic on Mtskheta Street","Shalamberidze, Levan","格鲁吉亚","Tbilisi","Tbilisi"],["VIAN","Zodelava, Manana","格鲁吉亚","Tbilisi","Tbilisi"],["HRF II - Hamburger Rheuma Forschungszentrum II","Everding, Andrea","德国","Hamburg","Hamburg"],["Universitaetsklinikum Freiburg","Finzel, Stephanie","德国","Baden Wuerttemberg","Freiburg"],["Klinikum der Universitaet Muenchen","Schulze-Koops, Hendrik","德国","Bayern","Muenchen"],["Medizinische Hochschule Hannover","Skripuletz, Thomas","德国","Niedersachsen","Hannover"],["University General Hospital","Boumpas, Dimitrios","希腊","Athens","Athens"],["NNA Hospital","Katsifis, Gkikas","希腊","Athens","Athens"],["General Hospital Papageorgiou","Papadopoulos, Nikolaos","希腊","Thessaloniki","Thessaloniki"],["Euroclinic of Athens","Skopouli, Foteini","希腊","Athens","Athens"],["General Hospital of Athens Laiko","Tzioufas, Athanasios","希腊","Athens","Athens"],["Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet","Kadar, Janos","匈牙利","Budapest","Budapest"],["Bekes Varmegyei Kozponti Korhaz","Martyin, Tibor","匈牙利","Gyula","Gyula"],["Debreceni Egyetem","Szanto, Antonia","匈牙利","Debrecen","Debrecen"],["Vita Verum Medical Egeszsegugyi Szolgaltato Bt.","Varga, Tunde","匈牙利","Szekesfehervar","Szekesfehervar"],["St Vincent's University Hospital","Orr, Carl","爱尔兰","Dublin","Dublin"],["Connolly Hospital - Blanchardstown","Valea, Adriana-Ramona","爱尔兰","Dublin 15","Dublin 15"],["Barzilai Medical Center","Ben Shimol, Jennifer","以色列","Ashkelon","Ashkelon"],["Meir Medical Center","Levy, Yair","以色列","Kfar- Sava","Kfar- Sava"],["Chaim Sheba Medical Center","Lidar, Merav","以色列","Ramat Gan","Ramat Gan"],["The Lady Davis Carmel Medical Center","Zisman, Devy","以色列","Haifa","Haifa"],["Stabilimento Ospedaliero Santa Chiara","Baldini, Chiara","意大利","Pisa","Pisa"],["Università Campus Bio-Medico di Roma","Berardicurti, Onorina","意大利","Roma","Roma"],["Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)","Nalli, Cecilia","意大利","Brescia","Brescia"],["Keio University Hospital","Akiyama, Mitsuhiro","日本","Tokyo-To","Shinjuku-ku"],["Hyogo Medical University Hospital","Azuma, Naoto","日本","Hyogo-Ken","Nishinomiya-shi"],["Kagawa University Hospital","Dobashi, Hiroaki","日本","Kagawa-Ken","Kita-gun"],["Osaka Metropolitan University Hospital","Hashimoto, Motomu","日本","Osaka-Fu","Osaka-shi"],["Hiroshima University Hospital","Hirata, Shintaro","日本","Hiroshima-Ken","Hiroshima-shi"],["Shimane University Hospital","Ichinose, Kunihiro","日本","Shimane-Ken","Izumo-shi"],["Tohoku Medical and Pharmaceutical University Hospital","Ishii, Tomonori","日本","Miyagi-Ken","Sendai-shi"],["Kanazawa University Hospital","Iwata, Yasunori","日本","Ishikawa-Ken","Kanazawa-shi"],["JCHO Chukyo Hospital","Kodera, Masanari","日本","Aichi-Ken","Nagoya-shi"],["Nagasaki University Hospital","Koga, Tomohiro","日本","Nagasaki-Ken","Nagasaki-shi"],["Hokkaido University Hospital","Kono, Michihito","日本","Hokkaido","Sapporo-shi"],["Kanazawa Medical University Hospital","Masaki, Yasufumi","日本","Ishikawa-Ken","Kahoku-gun"],["University of Tsukuba Hospital","Matsumoto, Isao","日本","Ibaraki-Ken","Tsukuba-shi"],["Nihon University Itabashi Hospital","Nakamura, Hideki","日本","Tokyo-To","Itabashi-ku"],["St. Luke's International Hospital","Ozawa, Hiroki","日本","Tokyo-To","Chuo-ku"],["Tohoku University Hospital","Sato, Hiroko","日本","Miyagi-Ken","Sendai-shiv"],["Fukushima Medical University Hospital","Sato, Shuzo","日本","Fukushima-Ken","Fukushima-Shi"],["Hamamatsu University School of Medicine, University Hospital","Shimoyama, Kumiko","日本","Shizuoka-Ken","Hamamatsu-shi"],["NHO Tokyo Medical Center","Suzuki, Katsuya","日本","Tokyo-To","Meguro-ku"],["Sasebo Chuo Hospital","Ueki, Yukitaka","日本","Nagasaki-Ken","Sasebo-shi"],["Pharmaceutical research center at Jordan University of Science and Technology","Ababenah, Fatemah","约旦","Irbid","Irbid"],["Jordan University Hospital","Adwan, Marwan","约旦","Amman","Amman"],["Abdali Hospital","Al Qurashi, Suhad","约旦","Amman","Amman"],["The Specialty Hospital Advanced Clinical Center","Hadidi, Mouse Al","约旦","Amman","Amman"],["Irbid Specialty Hospital","Shatnawi, Hani","约旦","Irbid","Irbid"],["Ajou University Hospital","Jung, Ju-Yang","大韩民国","Gyeonggi-do","Suwon"],["Hallym University Sacred Heart Hospital","Kim, Hyun Ah","大韩民国","Gyeonggi-do","Anyang-si"],["Istiklal Hospital","Rifaei, Sufian","约旦","Amman","Amman"],["Chonnam National University Hospital","Kim, Tae-Jong","大韩民国","Gwangju","Gwangju"],["Asan Medical Center","Kim, Yong-Gil","大韩民国","Seoul","Seoul"],["Soonchunhyang University Seoul Hospital","Lee, Kyung Ann","大韩民国","Seoul","Seoul"],["The Catholic University of Korea, St. Vincent's Hospital","Park, Yune-Jung","大韩民国","Gyeonggi-do","Suwon-si"],["Chung-Ang University Hospital","Song, Jung-Soo","大韩民国","Seoul","Seoul"],["Saint George Hospital University Medical Center","Azar, Lama","黎巴嫩","Beirut","Beirut"],["Ain Wazein Medical Village","Hilal, Nadeen","黎巴嫩","El Shouf","El Shouf"],["American University of Beirut Medical Center","Merashli, Mira","黎巴嫩","Beirut","Beirut"],["Hotel Dieu de France Hospital","Ziade, Nelly","黎巴嫩","Beirut","Beirut"],["Universitaetsklinikum Tuebingen","Henes, Joerg","德国","Baden Wuerttemberg","Tuebingen"],["Pecsi Tudomanyegyetem Klinikai Kozpont","Kumanovics, Gabor","匈牙利","Pecs","Pecs"],["Siauliai Republican Hospital, Public Institution","Basijokiene, Vida","立陶宛","Siauliai","Siauliai"],["Vilnius University Hospital Santaros Klinikos, Public Institution","Butrimiene, Irena","立陶宛","Vilnius","Vilnius"],["Inlita, JSC, Center of Santaros Clinical Trials","Lauciuviene, Ruta","立陶宛","Vilnius","Vilnius"],["Centro de investigacion medica y reumatologia","Aguilar Arreola, Jorge Enrique","墨西哥","Jalisco","Guadalajara"],["Unidad de Atencion Medica e Investigacion en Salud S.C.","Angulo Ramirez, Angelica Vanessa","墨西哥","Yucatán","Merida"],["Medical Care & Research SA de CV","Barrera Rodriguez, Aaron Alejandro","墨西哥","Yucatán","Merida"],["Centro Integral de Enfermedades Cronicas Durango CIDEC","Candia Zuniga, Dora Liliana","墨西哥","Durango","Durango"],["Consultorio Privado Dr. Miguel Cortes Hernandez","Cortes Hernandez, Miguel","墨西哥","Morelos","Cuernavaca"],["Centro de Atención e Investigación Cardiovascular del Potosí, S.C.","Dimas Pecina, Victor Manuel","墨西哥","San Luis Potos","San Luis Potosi"],["Clinica de Investigacion en Reumatologia y Obesidad S.C.","Duran Barragan, Sergio","墨西哥","Jalisco","Guadalajara"],["CAIMED INVESTIGACION EN SALUD, S.A. DE C.V.","Ferrusquia Toriz, Diana Laura","墨西哥","Distrito Federal","Mexico"],["Hospital Universitario Dr. Jose Eleuterio Gonzalez","Galarza Delgado, Dionicio Angel","墨西哥","Nuevo León","Monterrey"],["Unidad de Investigacion de las Enfermedades Reumaticas","Garcia Garcia, Conrado","墨西哥","Distrito Federal","Cuauhtemoc"],["Centro de Estudios de Investigacion Basica y Clinica SC","Garcia Valladares, Ignacio","墨西哥","Jalisco","Guadalajara"],["Centro de Investigacion de Tratamientos Innovadores de Sinaloa SC","Maradiaga Cecena, Marco Antonio","墨西哥","Sinaloa","Culiacan"],["Clinstile, S.A. de C.V.","Martinez Noriega, Juan Manuel","墨西哥","Distrito Federal","Ciudad de Mexico"],["CIMOVA (Consultorio anexo)","Morales Torres, Jorge Luis Alberto","墨西哥","Guanajuato","Leon"],["Centro de Investigacion y Atencion Integral Durango S.C.","Ortiz Jimenez, Enrique","墨西哥","Durango","Durango"],["Investigacion y Biomedicina de Chihuahua, Sociedad Civil","Pacheco Tena, Cesar Francisco","墨西哥","Chihuahua","Chihuahua"],["Centro de Investigacion en Reumatologia","Pinzon de la O, Blanca Irma","墨西哥","Yucatán","Mérida"],["Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.","Rizo Rodriguez, Juan Cruz","墨西哥","San Luis Potos","San Luis Potosi"],["CIMAB S.A. de C.V.","Sicsik Ayala, Sandra Araceli","墨西哥","Coahuila","Torreon"],["Panamerican Clinical Research Mexico S.A. de C.V. Guadalajara","Sierra Jimenez, Gabriela Margarita","墨西哥","Jalisco","Guadalajara"],["Cryptex Investigacion Clinica S.A. de C.V.","Vera Perez, Erika Maria","墨西哥","Distrito Federal","Mexico"],["Universitair Medisch Centrum Groningen","Bootsma, Hendrika","荷兰","Groningen","Groningen"],["Erasmus Medisch Centrum","van Daele, Paul","荷兰","Rotterdam","Rotterdam"],["Invest Clinicas Sac Inst de Ginecologia y Reproduccion","Calderon Gallegos, Julia Elena","秘鲁","Lima","Lima"],["Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic","Calvo Quiroz, Armando","秘鲁","Lima","Lima"],["Clinica El Golf","Cornejo Ortega, Mijahil Pavel","秘鲁","Lima","Lima"],["Clinica Medica Cayetano Heredia","Huamanchumo Guzman, Roberto Miguel","秘鲁","Lima","Lima"],["Clinica Internacional Sede San Borja","Rueda Fernandez, Carlos Alberto","秘鲁","Lima","Lima"],["Hospital Alberto Sabogal Sologuren","Salinas Meneses, Ariel","秘鲁","Lima","Lima"],["Hospital Nacional Cayetano Heredia","Zu？iga Corrales, Katiuska","秘鲁","Lima","Lima"],["St. Luke's Medical Center","Agbanlog, Aileen","菲律宾","Quezon City","Quezon City"],["The Medical City","Gutierrez Rubio, Anna Kristina","菲律宾","Ortigas","Ortigas"],["Ospital Ng Makati","Vista, Evan Glenn","菲律宾","Makati City, Metro Manila","Makati City, Metro Manila"],["Manila Doctors Hospital","Zamora, Geraldine","菲律宾","Manila","Manila"],["NSZOZ Termedica – Centrum Badan Klinicznych","Antkowiak-Piatyszek, Karolina","波兰","Poznan","Poznan"],["FutureMeds Lodz","Bartnicka Maslowska, Katarzyna","波兰","Lodz","Lodz"],["Malopolskie Badania Kliniczne","Batko, Bogdan","波兰","Krakow","Krakow"],["Ambulatorium Sp z o o","Bazela Ostromecka, Anna Barbara","波兰","Elblag","Elblag"],["ETG Siedlce","Bocianowski, Tomasz","波兰","Siedlce","Siedlce"],["FutureMeds Krakow","Borowy, Przemyslaw","波兰","Krakow","Krakow"],["Centrum Medyczne K2J2","Calus, Ewa","波兰","Czestochowa","Czestochowa"],["Nova Reuma Domys？awska i Rusi？owicz, Spó？ka Partnerska Lekarza Reumatologa i Fizjoterapeuty","Domyslawska, Izabela","波兰","Bialystok","Bialystok"],["Centrum Medyczne Pratia Katowice","Dziewit, Tomasz","波兰","Katowice","Katowice"],["MICS Centrum Medyczne Warszawa","Gryka-Marton, Malgorzata","波兰","Warszawa","Warszawa"],["Centrum Medyczne Intercor Sp. z o.o","Jankowski, Tomasz","波兰","Bydgoszcz","Bydgoszcz"],["Clinical Research Center Spó？ka z ograniczon？ odpowiedzialno？ci？ Medic-R Sp.k.","Jaraczewska-Baumann, Maria","波兰","Poznań","Poznań"],["FutureMeds Targowek","Jurek-Urbanowska, Agnieszka","波兰","Warsaw","Warsaw"],["Centrum Medyczne K2J2","Kaminska-Stachniak, Katarzyna","波兰","Wolomin","Wolomin"],["ETG Zamosc","Klimaszewska, Anna","波兰","Zamosc","Zamosc"],["MICS Centrum Medyczne Bydgoszcz","Kolossa, Katarzyna","波兰","Bydgoszcz","Bydgoszcz"],["ETG Lublin","Koszarny, Arkadiusz","波兰","Lublin","Lublin"],["FutureMeds Wroclaw","Krecipro Nizinska, Ewa","波兰","Wroclaw","Wroclaw"],["Clinical Trials Umed Sp.z o.o","Lewandowska Polak, Anna","波兰","Lodz","Lodz"],["Provita Profamilia","Maciejewska Przywojska, Beata","波兰","Piotrkow Trybunalski","Piotrkow Trybunalski"],["MCBK Iwona Czajkowska Anna Podra？ka- Szczepaniak S.C.","Malys Brylka, Anna","波兰","Grodzisk Mazowiecki","Grodzisk Mazowiecki"],["Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher","Maslinska, Maria","波兰","Warszawa","Warszawa"],["PRATIA S.A. MTZ Clinical Research Powered by Pratia","Rupinski, Robert","波兰","Warszawa","Warszawa"],["SOMED CR","Strzelecka, Anna","波兰","Lodz","Lodz"],["FutureMeds Gdynia","Szudejko, Katarzyna","波兰","Gdynia","Gdynia"],["Centrum Medyczne JustMed","Szwarc Bronikowska, Marta","波兰","Warszawa","Warszawa"],["REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler","Trefler, Jakub","波兰","Warszawa","Warszawa"],["Szpital Uniwersytecki nr 2 im.dr J. Biziela","Wojciechowski, Rafal","波兰","Bydgoszcz","Bydgoszcz"],["Centrum Medyczne Pratia Czestochowa","Wysocka-Znojkiewicz, Renata","波兰","Cz？stochowa","Cz？stochowa"],["Centrum Medyczne Reuma Park","Zubrzycka-Sienkiewicz, Anna","波兰","Warszawa","Warszawa"],["Reumed Spolka z o.o.","Zwolak, Roberta","波兰","Lublin","Lublin"],["Hospital CUF Descobertas","Barcelos, Filipe","葡萄牙","Lisboa","Lisboa"],["Hospital Conde de Bertiandos - Ponte de Lima (Unidade Local do Alto Minho, EPE)","Costa, Jose Antonio","葡萄牙","Ponte de Lima","Ponte de Lima"],["Unidade Local de Saude de Coimbra","Ines, Luis","葡萄牙","Coimbra","Coimbra"],["Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.","Pinto, Patricia","葡萄牙","Vila Nova de Gaia","Vila Nova de Gaia"],["Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria","Romao, Vasco","葡萄牙","Lisboa","Lisboa"],["S.C Delta Health Care S.R.L","Chicos, Bogdan Horia","罗马尼亚","Bucuresti","Bucuresti"],["S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L","Duca, Liliana","罗马尼亚","Brasov","Brasov"],["SC Aqua Med Consulting SRL","Ramazan, Ana Maria Mihaela","罗马尼亚","Constanta","Constanta"],["King Saud University Medical City","Al Omair, Mohammad","沙特阿拉伯","Riyadh","Riyadh"],["King Faisal Specialist Hospital & Research Center","AlFadda, Rayan","沙特阿拉伯","Riyadh","Riyadh"],["University Clinical Center of Serbia","Arandjelovic, Snezana","塞尔维亚","Belgrade","Belgrade"],["Special Hospital for Rheumatic Diseases","Boskovic, Ksenija","塞尔维亚","Novi Sad","Novi Sad"],["Institute of Rheumatology","Radunovic, Goran","塞尔维亚","Belgrade","Belgrade"],["ALBAMED s.r.o.","Ciernik, Silvia","斯洛伐克","Zvolen","Zvolen"],["ROMJAN s.r.o.","Jancovic, Roman","斯洛伐克","Bratislava","Bratislava"],["Narodny ustav reumatickych chorob","Lukacova, Olga","斯洛伐克","Piestany","Piestany"],["MEDMAN s.r.o.","Manka, Viliam","斯洛伐克","Martin","Martin"],["Artromac n.o.","Zarikova, Michaele","斯洛伐克","Kosice","Kosice"],["Hospital Quironsalud Infanta Luisa","Abdel-Kader Martin, Nadia","西班牙","Sevilla","Sevilla"],["Hospital Universitario Infanta Leonor","Akasbi Montalvo, Miriam","西班牙","Madrid","Madrid"],["Sanitas ES Sanitas Hospital CIMA","Brito Zeron, Maria Pilar","西班牙","Barcelona","Barcelona"],["Hospital Universitario Araba","Calvo Alen, Jaime","西班牙","Alava","Vitoria"],["Hospital Universitario de Badajoz","Chamizo, Eugenio","西班牙","Badajoz","Badajoz"],["Complejo Hospitalario Universitario A Coru？a","Freire Gonzalez, Mercedes","西班牙","La Coru？a","La Coru？a"],["Clinica GAIAS Santiago","Garcia Meijide, Juan Antonio","西班牙","La Coru？a","Santiago de Compostela"],["Hospital Universitario Ramon y Cajal","Guillen Astete, Carlos","西班牙","Madrid","Madrid"],["Hospital Universitari Vall d'Hebron","Marsal Barril, Sara","西班牙","Barcelona","Barcelona"],["Hospital Universitari Vall d'Hebron","Marsal Barril, Sara","西班牙","Barcelona","Barcelona"],["Hospital Universitario Fundacion Jimenez Diaz","Naredo Sanchez, Esperanza","西班牙","Madrid","Madrid"],["Hospital Clinico Universitario de Valencia","Trenor Larraz, Pilar","西班牙","Valencia","Valencia"],["Studieenheten Akademiskt Specialistcentrum","Antovic, Aleksandra","瑞典","Stockholm","Stockholm"],["Hopital Regional Mohamed Taher El Maamouri","Amri, Raja","突尼斯","Nabeul","Nabeul"],["Hopital Habib Thameur","Boussema, Fatma","突尼斯","Montfleury Tunis","Montfleury Tunis"],["Hedi Chaker Hospital","Frikha, Faten","突尼斯","Sfax","Sfax"],["Hospital Farhat Hached","Ghannouchi, Neirouz","突尼斯","Sousse","Sousse"],["Karadeniz Tecnical Uni. Med. Fac.","Capkin, Erhan","土耳其","Trabzon","Trabzon"],["Gazi University Medical Faculty","Goker, Berna","土耳其","Ankara","Ankara"],["Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty","Hatemi, Gulen","土耳其","Istanbul","Istanbul"],["Hacettepe University Medical Faculty","Kilic, Levent","土耳其","Ankara","Ankara"],["Royal Hallamshire Hospital","Akil, Mohammed","英国","West Midlands","Sheffield"],["Southampton General Hospital","Edwards, Christopher","英国","Hampshire","Southampton"],["Cannock Chase Hospital","Sheeran, Thomas","英国","Staffordshire","Cannock"],["Arizona Arthritis & Rheumatology Research, PLLC","Amin, Mona","美国","Arizona","Sun City"],["Carilion Clinic","Bankole, Adegbenga","美国","Virginia","Roanoke"],["Precision Comprehensive Clinical Research Solution","Basavaraju, Renuka","美国","Texas","Colleyville"],["Arizona Arthritis & Rheumatology Research, PLLC","Cabacungan, Romy","美国","Arizona","Tucson"],["Clinical Research of West Florida, Inc.","Carter, John","美国","Florida","Tampa"],["Arizona Arthritis & Rheumatology Research, PLLC","Chudhri, Shariq","美国","Texas","Irving"],["Greater Chicago Specialty Physicians LLC","Conniff, Cory","美国","Illinois","Orland Park"],["Arizona Arthritis & Rheumatology Research, PLLC","Crowley, Angela","美国","Illinois","Willowbrook"],["Finlay Medical Research Corp","Cure Lopez, Zabeth","美国","Florida","Greenacres"],["Southwest Family Medicine Associates","Dharma, Chrisette","美国","Texas","Dallas"],["Conquest Research","Feller, Lance","美国","Florida","Winter Park"],["Velocity Clinical Research Waco","Fung, HS Eugene","美国","Texas","Waco"],["Joseph S. and Diane H. Steinberg Ambulatory Care Center","Goddard, David","美国","New York","Brooklyn"],["Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research","Jain, Manish","美国","Illinois","Chicago"],["Samaritan Health Services","Jones, Jonathan","美国","Oregon","Corvallis"],["University of Florida College of Medicine Jacksonville","Kaeley, Gurjit","美国","Florida","Jacksonville"],["Columbia University","Kapoor, Teja","美国","New York","New York"],["R and H Clinical Research","Khawari, Maryam","美国","Texas","Katy"],["Allen Arthritis","Lavery, John","美国","Texas","Allen"],["Clinical Research of West Florida, Inc.","Levin, Robert","美国","Florida","Clearwater"],["Chicago Clinical Research Institute","Levinson, Dennis","美国","Illinois","Chicago"],["St. Luke's Clinic - Rheumatology","Loveless, James","美国","Idaho","Boise"],["East Penn Rheumatology Associates, P.C.","Ludivico, Charles","美国","Pennsylvania","Bethlehem"],["Piedmont Healthcare, Inc.","Machua, Wambui","美国","Georgia","Atlanta"],["Accurate Clinical Research Inc.","Mendez, Enrique","美国","Louisiana","Lake Charles"],["Accurate Clinical Research","Najam, Sabeen","美国","Texas","Baytown"],["Providence Medical Foundation","Pang, Shirley","美国","California","Fullerton"],["Washington University School of Medicine","Parks, Deborah","美国","Missouri","St. Louis"],["North Houston Arthritis Center","Peer, Adnan","美国","Texas","Houston"],["Arizona Arthritis & Rheumatology Research, PLLC","Reddy, Himabindu","美国","Texas","Fort Worth"],["One of a Kind Clinical Research Center LLC","Rizwan, Mian","美国","Arizona","Scottsdale"],["Life Clinical Trials","Shah, Jigar","美国","Florida","Margate"],["Centre for Rheumatology, Immunology and Arthritis","Sherrer, Yvonne","美国","Florida","Fort Lauderdale"],["Simcare Medical Research LLC","Siddiqui, Imran","美国","Texas","Sugar Land"],["University of California San Diego","Smith, Chelsey","美国","California","La Jolla"],["Tekton Research - Fort Collins","Thakor, Michael","美国","Colorado","Fort Collins"],["Rheumatology Center Of Houston","Vo, Jacqueline","美国","Texas","Pearland"],["Accurate Clinical Research, Inc.","Waller, Philip","美国","Texas","Houston"],["University of Colorado","Weinstein, Elena","美国","Colorado","Aurora"],["Novel Research LLC","Yousaf, Wajeeha","美国","Texas","Bellaire"],["University of Iowa Hospital and Clinics","Zembrzuska, Hanna","美国","Iowa","Iowa"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院北京协和医院药物临床试验伦理委员会","修改后同意","2025-03-19"],["中国医学科学院北京协和医院药物临床试验伦理委员会","同意","2025-04-07"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 116 ； 国际: 580 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 35 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2024-12-17；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-03-04；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；