上海JNJ-77242113-AAC片III期临床试验-一项在接受过生物制剂治疗的活动性银屑病关节炎受试者中评价Icotrokinra (JNJ-77242113) 疗效和安全性的研究 (ICONIC-PsA 2)

登记号	CTR20244975	试验状态	进行中
申请人联系人	王睿	首次公示信息日期	2024-12-31
申请人名称	Janssen Research & Development, LLC/ 强生（中国）投资有限公司/ Janssen Pharmaceutica NV; Janssen-Cilag SpA/ Janssen Pharmaceutica NV; Janssen-Cilag SpA; Fisher Clinical Services Inc.; Fisher Clinical Services GmbH

登记号	CTR20244975
相关登记号	暂无
药物名称	JNJ-77242113-AAC片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	银屑病关节炎
试验专业题目	一项评价JNJ-77242113用于接受过生物制剂治疗的活动性银屑病关节炎受试者的疗效和安全性的III期、多中心、随机、双盲、安慰剂对照研究
试验通俗题目	一项在接受过生物制剂治疗的活动性银屑病关节炎受试者中评价Icotrokinra (JNJ-77242113) 疗效和安全性的研究 (ICONIC-PsA 2)
试验方案编号	77242113PSA3002	方案最新版本号	修正案1
版本日期:	2024-12-02	方案是否为联合用药	否

申请人名称	[["Janssen Research & Development, LLC"],["强生（中国）投资有限公司"],["Janssen Pharmaceutica NV; Janssen-Cilag SpA"],["Janssen Pharmaceutica NV; Janssen-Cilag SpA; Fisher Clinical Services Inc.; Fisher Clinical Services GmbH"]]
联系人姓名	王睿	联系人座机	010-58218888	联系人手机号
联系人Email	rwang72@its.jnj.com	联系人邮政地址	北京市-北京市-北京市朝阳区建国路77号19层1901室	联系人邮编	100022

本研究的目的是通过评估icotrokinra与安慰剂相比对活动性银屑病关节炎(PsA)受试者体征和症状减轻的疗效

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	[["不小于18岁（或研究实施所在司法辖区的法定同意年龄）。"],["在研究药物首次给药前至少3个月被诊断为PsA，且在筛选时符合银屑病关节炎分类标准（CASPAR）。"],["患有活动性PsA，定义如下：a.t筛选时和基线时有至少3个肿胀关节和至少3个触痛关节。b.t筛选时中心实验室检查的C-反应蛋白（CRP）≥0.1 mg/dL。"],["存在至少1种以下PsA亚型：远端指间关节受累、无类风湿性结节的多关节型关节炎、损毁性关节炎、不对称外周关节炎或脊柱炎伴外周关节炎。"],["患有活动性斑块状银屑病，有至少一个直径≥2 cm的银屑病斑块或与银屑病相符的指甲改变。"],["受试者既往必须接受过1种生物制剂治疗PsA或银屑病，且必须记录停药原因。"],["如果当前正在使用非生物类DMARD，则受试者应在研究药物首次给药前至少12周开始治疗且在研究药物首次给药前必须接受了至少4周的稳定剂量治疗，且不得有非生物类DMARD引起的严重毒副作用。如果当前未使用甲氨蝶呤(MTX)、柳氮磺吡啶(SSZ)或羟氯喹(HCQ)，则在研究药物首次给药前至少4周内不得使用这些药物。如果当前未使用来氟米特(LEF)，则在研究药物首次给药前至少12周内不得使用该药物。"],["有生育能力的女性受试者在筛选时的高灵敏度血清妊娠试验（β人绒毛膜促性腺激素[β-hCG]）和第0周研究药物给药前的尿妊娠试验均必须呈阴性。"],["女性受试者在入组本研究期间和研究药物末次给药后4周内不得怀孕、哺乳或计划怀孕。"],["女性受试者必须同意在研究期间和研究药物末次给药后至少4周内不以辅助生殖为目的捐献卵子（卵细胞、卵母细胞）或冷冻卵子以供将来使用。"],["女性受试者必须符合：a）无生育能力，或 b）有生育能力且目前正采用高效避孕方法，并同意在研究药物给药期间和末次给药后4周内持续使用高效避孕方法。"],["男性受试者必须同意在入组本研究期间和研究药物末次给药后90天内不得有生育计划。"],["在研究期间和研究药物末次给药后90天内，未行输精管切除术的男性受试者必须同意在与有生育能力的女性发生性行为时使用屏障避孕法。"],["男性受试者必须同意在研究期间研究药物末次给药后至少90天内不因生殖目的而捐献精子或冷冻精子。"],["受试者必须签署知情同意书（ICF），表明他们理解研究的目的和所需要的程序，并且愿意参与本研究。"],["如果受试者同意提供可选DNA样本供研究使用（如果当地法规允许），受试者必须签署单独的ICF。"],["愿意并能够遵守本研究方案中规定的生活方式限制，包括同意避免长时间日光照射，并同意在研究期间不使用日光浴或其他紫外线（UV）光源（针对有皮肤病损的受试者）。"],["同意在研究期间或在研究药物末次给药后4周内不接受活病毒疫苗接种。"]]
排除标准	[["有严重、进展性或控制不佳的肾脏、肝脏、心脏、血管、肺、胃肠、内分泌、神经系统、血液学、风湿类、精神类、泌尿生殖系统或代谢障碍疾病史或当前存在体征或症状。"],["目前罹患恶性肿瘤或筛选前5年内有恶性肿瘤史。"],["已知对Icotrokinra或其辅料存在过敏、超敏反应或不耐受。"],["患有不稳定的心血管疾病，定义为筛选前12周内出现临床恶化或筛选前12周内因心脏疾病住院。"],["患有可能混淆Icotrokinra治疗获益评价的其他炎症性疾病，包括但不限于 类风湿性关节炎（RA）、系统性红斑狼疮或莱姆病。"],["受试者有研究者认为可能干扰疗效评估的纤维肌痛或骨关节炎症状。"],["有淋巴细胞增生性疾病史，包括淋巴瘤；有意义不明的单克隆丙种球蛋白病史；或提示可能存在淋巴细胞增生性疾病的体征和症状，如淋巴结病或脾肿大。"],["有慢性或复发性感染性疾病史。"],["接受过器官移植术（研究药物首次给药前＞12周接受过角膜移植的情况除外）。"],["有人工关节感染病史，或者曾因人工关节疑似感染而接受过抗生素治疗，前提是该人工关节未被移除或置换。"],["当前患有带状疱疹感染，或筛选前8周内发生过带状疱疹感染。"],["患有非斑块状银屑病。"],["当前患有药物诱导性银屑病。"],["已知存在或疑似免疫缺陷，包括侵袭性机会感染史或存在频率异常或持续时间延长的复发性感染，尽管感染最终消退，但经研究者判定提示免疫功能受损。"],["符合以下任何一项TB筛选标准：a）筛选时有活动性TB病史或提示活动性TB的体征或症状。b）在进一步的病情检查（根据当地实践/指南）确定没有证据表明受试者患有活动性TB的情况下，检测结果为阳性（或不确定）的受试者可以参加研究。如果确定受试者存在潜伏性TB，根据当地卫生监管机构的规定和研究者的判断，复发风险低的受试者在研究前或研究期间不需要接受预防性抗结核治疗。"],["在筛选前8周内接受过重大手术，或预计无法从此类手术中完全康复，或在预计参加研究的时间内有此类手术安排。"],["筛选时的实验室检查结果符合方案规定的参数要求。"],["根据中心实验室标准，筛选时类风湿因子或抗CCP抗体呈阳性。"],["既往接受过Icotrokinra治疗。"],["研究药物首次给药前2周使用过可能影响银屑病评价的外用药物/治疗，包括但不限于外用或病灶内注射糖皮质激素、地蒽酚、卡泊三醇、外用维生素D衍生物、Tapinarof、Roflumilast、维甲酸、他扎罗汀、甲氧沙林、三甲基补骨脂素、吡美莫司、他克莫司或中草药。"],["研究药物首次给药前4周曾接受除甲氨蝶呤以外的任何全身性免疫抑制剂。"],["研究药物首次给药前12周接受过细胞毒性药物。"],["研究药物首次给药前4周接受过非生物类DMARD。"],["研究药物首次给药前4周接受过光疗或可能影响银屑病评价的任何全身性药物/治疗。"],["研究药物首次给药前4周接受过硬膜外、关节内、肌内（IM）或IV糖皮质激素给药，包括促肾上腺皮质激素。"],["研究药物首次给药前4周接受过短期（≤2周）或长期（＞2周）口服糖皮质激素治疗非PsO或PsA适应症。"],["既往接受过以下药物治疗PsA或银屑病： JAK抑制剂； TYK抑制剂。"],["既往接受过任何生物类DMARD治疗PsA或银屑病。"],["既往接受过以下生物制剂治疗PsA或银屑病：抗TNFα药物或生物类似药、抗IL-17药物或生物类似药或阿巴西普或生物类似药。"],["研究药物首次给药前26周因任何适应症使用B细胞耗竭药物。"],["研究药物首次给药前12周或5个半衰期（以较长者为准）接受过任何其他（非PsO、PsA适应症）生物制剂治疗。"],["研究药物首次给药前4周接受过或计划接受任何活病毒或活菌疫苗接种。"],["研究药物首次给药前12个月接受过或计划接受卡介苗（BCG）接种。"],["在计划的研究药物首次给药前90天或5个半衰期内（以较长者为准）接受过试验用药物或使用过有创性试验用医疗器械。"],["筛选前26周内有自杀意念的所有受试者。"],["研究药物首次给药前4周内，COVID-19检测呈阳性或有COVID-19暴露史。"],["乙型肝炎病毒（HBV）感染检测呈阳性或筛选时丙型肝炎病毒（HCV）抗体血清阳性。"],["在研究药物首次给药前12周内的胸部X线检查（或CT扫描）证实当前存在持续感染或恶性肿瘤。"],["研究者或研究中心的雇员，直接参与本研究或研究者/研究中心负责的其他研究，以及研究者或雇员的家属。"],["因为耐受性较差或静脉条件较差，无法或不愿意接受多次静脉穿刺。"],["依法庭或政府命令居住在特定机构或法庭或政府认为脆弱的受试者。"],["申办方的雇员。"],["存在研究者认为参加本研究并非其最佳选择或者影响、限制或混淆研究方案评估的病症。"],["根据DSM-5标准，筛选前1年内有药物或酒精滥用史；使用大麻的患者不在排除之列（如果当地法规允许），除非经研究者判断为滥用。"]]

试验药

[["中文通用名:Icotrokinra 英文通用名:Icotrokinra 商品名称:Icotrokinra","剂型:片剂 规格:不适用 用法用量:组I接受每日一次Icotrokinra剂量1至第52周组II接受每日一次Icotrokinra剂量2至第52周组III接受安慰剂每日一次至第16周，在第16周时交叉接受Icotrokinra每日一次剂量1或剂量2LTE入组延长期将接受每日一次Icotrokinra剂量1或剂量2至第100周 用药时程:组I和组II的受试者将接受Icotrokinra片剂每日一次给药直至第52周组III:受试者从第16周开始将交叉接受Icotrokinra剂量1或剂量2每日一次给药。入组延长期的受试者将继续接受剂量1或剂量2Icotrokinra每日一次给药，直至第100周"],["中文通用名:Icotrokinra 英文通用名:Icotrokinra 商品名称:Icotrokinra","剂型:片剂 规格:不适用 用法用量:组I接受每日一次Icotrokinra剂量1至第52周组II接受每日一次Icotrokinra剂量2至第52周组III接受安慰剂每日一次至第16周，在第16周时交叉接受Icotrokinra每日一次剂量1或剂量2LTE入组延长期将接受每日一次Icotrokinra剂量1或剂量2至第100周 用药时程:组I和组II的受试者将接受Icotrokinra片剂每日一次给药直至第52周组III:受试者从第16周开始将交叉接受Icotrokinra剂量1或剂量2每日一次给药。入组延长期的受试者将继续接受剂量1或剂量2Icotrokinra每日一次给药，直至第100周"]] 序号 名称 用法

对照药

[["中文通用名:匹配安慰剂 英文通用名:Matchingplacebo 商品名称:不适用","剂型:片剂 规格:不适用 用法用量:组I接受安慰剂1片每日一次至第52周，进入延长期将接受安慰剂1片每日一次至第100周组III接受安慰剂2片至第16周并在第16周交叉转为接受剂量1或剂量2icotrokinra。接受剂量1的受试者将每日服用1片安慰剂至第52周，进入延长期的受试者将接受安慰剂1片每日一次至第100周 用药时程:组1受试者将接受匹配安慰剂每日一次直至第52周，组3受试者将接受匹配安慰剂每日一次直至第16周。在第16周接受剂量1incotrokinra治疗的受试者将接受1片匹配安慰剂直到第100周，如果该受试者进入延长期（LTE）。"]] 序号 名称 用法

主要终点指标及评价时间

[["第16周时的美国风湿病学会（ACR）20应答","第16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

[["第16周时的PASI 75应答（针对基线BSA≥3%且基线IGA评分≥2分的受试者）","第16周","有效性指标"],["第16周时的PASI 90应答（针对基线BSA≥3%且基线IGA评分≥2分的受试者）","第16周","有效性指标"],["第16周时的PASI 100应答（针对基线BSA≥3%且基线IGA评分≥2分的受试者）","第16周","有效性指标"],["第16周时IGA为0/1分且较基线改善≥2级（针对基线BSA≥3%且基线IGA评分≥2分的受试者）","第16周","有效性指标"],["第16周时的ACR50应答","第16周","有效性指标"],["第16周时的ACR70应答","第16周","有效性指标"],["第16周时HAQ-DI评分较基线的变化","从基线到第16周","有效性指标"],["第16周时SF-36 PCS较基线的变化","从基线到第16周","有效性指标"],["基线时患有附着点炎的患者在第16周时附着点炎消退","第16周","有效性指标"],["基线时患有附着点炎的患者在第16周时附着点炎评分较基线的变化","基线和第16周","有效性指标"],["基线时患有指（趾）炎的患者在第16周时指（趾）炎消退","第16周","有效性指标"],["基线时患有指（趾）炎的患者在第16周时指（趾）炎评分较基线的变化","从基线到第16周","有效性指标"],["第16周时的MDA","第16周","有效性指标"],["第16周时FACIT-疲劳评分较基线的变化","从基线到第16周","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	邹和建	学位	医学博士	职称	主任医师
	电话	86 021-5288 8291	Email	hjzou@fudan.edu.cn	邮政地址	上海市-上海市-上海市静安区乌鲁木齐中路12号
	邮编	200040	单位名称	复旦大学附属华山医院

[["复旦大学附属华山医院","邹和建","中国","上海市","上海市"],["复旦大学附属华山医院","万伟国","中国","上海市","上海市"],["上海市皮肤病医院","丁杨峰","中国","上海市","上海市"],["西安交大第二附属医院","李学义","中国","陕西省","西安市"],["北京大学第三医院","穆容","中国","北京市","北京市"],["四川大学华西医院","赵毅","中国","四川省","成都市"],["四川省人民医院","朱静","中国","四川省","成都市"],["吉林大学白求恩第一医院","姜振宇","中国","吉林省","长春市"],["临沂市人民医院","李尊忠","中国","山东省","临沂市"],["中南大学湘雅医院","粟娟","中国","湖南省","长沙市"],["温州医科大学附属第一医院","孙莉","中国","浙江省","温州市"],["首都医科大学附属北京同仁医院","魏爱华","中国","北京市","北京市"],["南昌大学第二附属医院","段新旺","中国","江西省","南昌市"],["萍乡市人民医院","胡建康","中国","江西省","萍乡市"],["深圳市人民医院","刘冬舟","中国","广东省","深圳市"],["南通大学附属医院","达展云","中国","江苏省","南通市"],["南方医科大学南方医院","李娟","中国","广东省","广州市"],["山西白求恩医院","张莉芸","中国","山西省","太原市"],["苏州大学附属第二医院","刘志纯","中国","江苏省","苏州市"],["贵州医科大学附属医院","曾家顺","中国","贵州省","贵阳市"],["重庆医科大学附属第一医院","陈爱军","中国","重庆市","重庆市"],["嘉兴市第一医院","王宏智","中国","浙江省","嘉兴市"],["浙江大学医学院附属邵逸夫医院","韩咏梅","中国","浙江省","杭州市"],["金华市中心医院","杜红卫","中国","浙江省","金华市"],["Prince of Wales Hospital","Lai Shan Tam","中国香港","香港特别行政区","新界"],["Queen Mary Hospital","Iris Yan Ki Tang","中国香港","香港特别行政区","香港岛"],["Chi Mei Medical Center","Hung An Chen","中国台湾","台湾省","台南"],["Taipei Veterans General Hospital","Wei Sheng Chen","中国台湾","台湾省","台北"],["National Taiwan University Hospital Hsin Chu Branch","Hsien Yi Chiu","中国台湾","台湾省","新竹"],["Linkou Chang Gung Memorial Hospital","Yao Fan Fang","中国台湾","台湾省","桃园"],["Taipei Medical University Shuang Ho Hospital","Sheng Hong Lin","中国台湾","台湾省","新北"],["Kaohsiung Chang Gung Memorial Hospital","Yu Jih Su","中国台湾","台湾省","高雄"],["National Cheng Kung University Hospital","Meng Yu Weng","中国台湾","台湾省","台南"],["Arsema","Federico Ariel","阿根廷","Buenos Aires","Ciudad de Buenos Aires"],["Centro Medico Privado de Reumatologia Tucuman","Horacio Berman","阿根廷","Tucuman","Ciudad de San Miguel de Tucuman"],["Cer Instituto Medico","Graciela Betancur","阿根廷","Buenos Aires","Quilmes"],["Hospital Militar Central Cir. My. Dr. Cosme Argerich","Gustavo Casado","阿根廷","Cdad Autonoma de Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Mindout Research","Raul Hernan Gabriel Ceitlin","阿根廷","Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Instituto de Investigaciones Clinicas Quilmes","Yamila Chichotky","阿根廷","Buenos Aires","Quilmes"],["Cosultorios Reumatologogicos Pampa","Maria de los Angeles Correa","阿根廷","Buenos Aires","Ciudad autonoma de Buenos Aires"],["MR Medicina Reumatologica","lejandra Cusa","阿根廷","Buenos Aires","San Fernando"],["Centro de Investigaciones Medicas","Carolina Iturralde","阿根廷","Provincia de Buenos Aires","Mar del Plata"],["Instituto Medico De Alta Complejidad (IMAC)","Maria Alicia Lazaro","阿根廷","Buenos Aires","Buenos Aires"],["ARCIS Salud SRL Aprillus asistencia e investigacion","Pablo Alejandro Mannucci Walter","阿根廷","Buenos aires","Buenos aires"],["Hospital Cordoba","Veronica Gabriela Savio","阿根廷","Cordoba","Cordoba"],["INSTITUTO CAICI SRL.","Daniel Siri","阿根廷","Santa Fe","Rosario"],["Rheumatology Research Unit","Peter Nash","澳大利亚","QLD","Maroochydore"],["Queen Elizabeth Hospital","Maureen Rischmueller","澳大利亚","SA","South Woodville"],["Royal Darwin Hospital","Maureen Rischmueller","澳大利亚","Northern Territory","Tiwi"],["Royal North Shore Hospital","Premarani Sinnathurai","澳大利亚","NSW","St Leonards"],["Ipswich Hospital","Kevin Su","澳大利亚","QLD","Ipswich"],["Universidade Federal de Minas Gerais UFMG Faculdade de Medicina","Jorge Andrade Pinto","巴西","MG","Belo Horizonte"],["Hospital das Clinicas de Porto Alegre","Claiton Brenol","巴西","RS","Porto Alegre"],["Chronos Clinica Medica LTDA Chronos Pesquisa Clinica","Camila Calado","巴西","DF","Brasilia"],["Associacao Hospitalar Moinhos de Vento","Cecilia Costa","巴西","RS","Porto Alegre"],["CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos","Flora Maria D'Andrea Marcolino","巴西","SP","Sao Paulo"],["Science Vale Consultoria Pesquisa e Desenvolvimento na Area Medica Ltda","Ricardo Golmia","巴西","SP","Sao Paulo"],["LMK Servicos Medicos S S","Mauro Keiserman","巴西","RS","Porto Alegre"],["Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP","Rodrigo Luppino Assad","巴西","SP","Ribeirao Preto"],["Hospital Parana Parana Medical Research Center","Felipe Merchan Ferraz Grizzo","巴西","PR","Maringa"],["Hospital Lifeplus Litoral Norte Ltda","Penelope Palominos","巴西","RS","Xangrila"],["Instituto D Or de Pesquisa e Ensino","Gustavo Pinto","巴西","BA","Salvador"],["Empresa Brasileira De Servicos Hospitalares EBSERH Hospital De Clinicas De Uberlandia","Roberto Ranza","巴西","MG","Uberlandia"],["Hospital Das Clinicas Da Faculdade De Medicina Da USP","Carla Saad","巴西","SP","Sao Paulo"],["BR TRIALS Ensaios Clinicos e Consultoria Ltda","Felipe Santana","巴西","SP","Sao Paulo"],["Platano Centro De Pesquisa Clinica LTDA","Rafaela Silva Guimaraes Goncalves","巴西","PE","Recife"],["Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base","Ricardo Toledo","巴西","SP","Sao Jose Do Rio Preto"],["UMHAT Kaspela","Anastas Batalov","保加利亚","Plovdiv","Plovdiv"],["Medical Center Artmed","Mariela Geneva Popova","保加利亚","Plovdiv","Plovdiv"],["Multiprofile Hospital for Active Treatment Plovdiv","Ivan Goranov","保加利亚","Plovdiv","Plovdiv"],["MHAT Pleven","Tihomir Gorchev","保加利亚","Pleven","Pleven"],["Diagnostic-Consultative Center (DCC) Aleksandrovska","Delina Ivanova","保加利亚","Sofia Grad","Sofia"],["Diagnostic Consulting Center I Sliven","Aneliya Koleva","保加利亚","Sliven","Sliven"],["MC Medtech Services Ltd","Krasimir Kraev","保加利亚","Sofia Grad","Sofia"],["ASIMP Rheumatology Centre St Irina EOOD","Rodina Licheva","保加利亚","Sofia Grad","Sofia"],["MC Ekselsior","Tzvetanka Petranova","保加利亚","Sofia Grad","Sofia"],["Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD","Aneliya Radikova","保加利亚","Sofia Grad","Sofia"],["DCC Fokus 5 LZIP OOD","Rasho Rashkov","保加利亚","Sofia Grad","Sofia"],["UMHAT St. Ivan Rilski","Rasho Rashkov","保加利亚","Sofia Grad","Sofia"],["Medical Center Teodora","Margarita Velkova","保加利亚","Ruse","Ruse"],["GRMO Groupe de recherche en maladies osseuses Inc","Louis Bessette","加拿大","Quebec","Quebec"],["York Dermatology Clinic and Research Centre","Michael Cecchini","加拿大","ON","Richmond Hill"],["Toronto Western Hospital","Vinod Chandran","加拿大","ON","Toronto"],["Womens College Hospital","Lihi Eder","加拿大","ON","Toronto"],["The Waterside Clinic","Derek Haaland","加拿大","ON","Orillia"],["Centre de Recherche Musculo Squelettique","Frederic Morin","加拿大","QC","Trois Rivieres"],["Alliance Clinical Trials","Kim Papp","加拿大","ON","Waterloo"],["Eastern Regional Health Authority St Clares Mercy Hospital","Proton Rahman","加拿大","NL","St Johns"],["Dermatrials Research","Ronald Vender","加拿大","ON","Hamilton"],["CCR Ostrava S R O","Sylva Brtnikova","捷克","Moravian-Silesian","Ostrava"],["Medical Plus S R O","Eva Dokoupilova","捷克","Zliin","Uherske Hradiste"],["FN Motol","Rudolf Horvath","捷克","Prague","Praha"],["Thomayerova nemocnice","Petr Kopsa","捷克","Prague","Praha"],["Revmacentrum MUDr Mostera s r o","Erik Moster","捷克","Jihomoravsky kraj","Brno"],["L K N Arthrocentrum","Libor Novosad","捷克","Moravian-Silesian","Hlucin"],["Revmatologie s r o","Leona Prochazkova","捷克","Jihomoravsky kraj","Brno"],["MUDr Rosypalova s r o","Miroslava Rosypalova","捷克","Moravskoslezsky kraj","Ostrava"],["RHEUMA s r o","Jaroslava Spevakova","捷克","South Moravian","Breclav"],["Revmatologicka ambulance","Zuzana Stejfova","捷克","Prague","Praha 4"],["Revmatologicky ustav","Jana Tomasova Studynkova","捷克","Prague","Praha"],["PV Medical S R O","Petr Vitek","捷克","Zlin","Zlin"],["Frederiksberg Hospital","Bjarke Brandt Hansen","丹麦","Frederiksberg Kommune","Frederiksberg"],["Koge Sygehus Region Sjaelland","Ada Colic","丹麦","Region Zealand","Koge"],["Sydvestjysk Sygehus","Philip Rask Hansen","丹麦","Region Syddanmark","Esbjerg"],["Aarhus University Hospital","Ellen Margrethe Hauge","丹麦","Central Denmark Region","Aarhus N"],["Svendborg Hospital Odense University Hospital","Soeren Andreas Just","丹麦","Region of Southern Denmark","Svendborg"],["Sanos Clinic","Salome Kristensen","丹麦","Nordjylland","Gandrup"],["Vejle Sygehus","Myriam Liz Grana","丹麦","Region of Southern Denmark","Vejle"],["Regionshospitalet Godstrup","Rene Drage Oestgaard","丹麦","Central Denmark Region","Herning"],["Rheumazentrum Ruhrgebiet","Ioana Andreica","德国","Nordrhein Westfalen","Herne"],["Johannes Wesling Klinikum Minden","Gunter Assmann","德国","Nordrhein Westfalen","Minden"],["Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden","Stefan Beissert","德国","SN","Dresden"],["Hamburger Rheuma Forschungszentrum II","Andrea Everding","德国","HH","Hamburg"],["Medizinische Fakultaet Der Albert Ludwigs Universitaet Freiburg","Stephanie Finzel","德国","BW","Freiburg Im Breisgau"],["Universitatsklinikum Tubingen","Matthias Hahn","德国","Baden-Württemberg","Tubingen"],["Fachklinik Bad Bentheim","Thomas Rath","德国","Niedersachsen","Bad Bentheim"],["Universitatsklinikum Schleswig Holstein","Gabriela Riemekasten","德国","Schleswig-Holstein","Lubeck"],["Praxis Dr. med. Beate Schwarz - Germany","Beate Schwarz","德国","Baden-Wurttemberg","Langenau"],["ISA - Interdisciplinary Study Association GmbH","Margrit Simon","德国","BE","Berlin"],["Charite - Campus Mitte","David Nils Simon","德国","BE","Berlin"],["Krankenhaus Porz am Rhein","Johannes Strunk","德国","Nordrhein-Westfalen","Koln"],["Rheumaforschung - Studienambulanz Dr. Wassenberg","Siegfried Wassenberg","德国","North Rhine-Westphalia","Ratingen"],["Universitatsklinikum Erlangen Medizinische Klinik 3","Andreas Wirsching","德国","Bavaria","Erlangen"],["Uno Medical Trials Ltd.","Eva Apostol","匈牙利","Pest megye","Budapest"],["University of Szeged","Attila Balog","匈牙利","Csongrad-Csanád County","Szeged"],["Debreceni Egyetem Reumatologiai Klinika","Nora Bodnar","匈牙利","Hajdu-Bihar County","Debrecen"],["Obudai Egeszsegugyi Centrum Kft","Viktoria Csonka","匈牙利","Somogy County","Kaposvar"],["Vital Medical Center Orvosi es Fogaszati Kozpont","Edit Drescher","匈牙利","Veszprem County","Veszprem"],["Synexus Magyarorszag Kft","Katalin Guba","匈牙利","Pest megye","Budapest"],["Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz","Peter Keszthelyi","匈牙利","Bekes County","Gyula"],["Revita Kft","Marta Megyaszai","匈牙利","Pest megye","Budapest"],["Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz","Judit Pulai","匈牙利","Fejer County","Szekesfehervar"],["Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz","Bernadette Rojkovich","匈牙利","Pest megye","Budapest"],["MAV Korhaz es Rendelointezet","Laszlo Samson","匈牙利","Jasz-Nagykun-Szolnok County","Szolnok"],["Qualiclinic Kft","Istvan Szombati","匈牙利","Pest megye","Budapest"],["Bacs Kiskun Varmegyei Oktatokorhaz","Katalin Torocsik","匈牙利","Bacs-Kiskun County","Kecskemet"],["JSS Hospital","Shiva Prasad B N","印度","Karnataka","Mysuru"],["Apollo Multispeciality Hospital Ltd","Syamasis Bandyopadhyay","印度","West Bengal","Kolkata"],["Sushruta Multispeciality Hospital","Vikram Haridas","印度","KA","Hubballi"],["Sir Ganga Ram Hospital","Atul Kakar","印度","Delhi","New Delhi"],["All India Institute of Medical Sciences","Uma Kumar","印度","DL","New Delhi"],["Calicut Government Medical college","Neeraj Manikath","印度","Kerala","Kozhikode"],["Kokilaben Dhirubhai Ambani Hsp And Med Research Inst","Jyotsna Oak","印度","MH","Mumbai"],["Fortis Hospital","Bimlesh Pandey","印度","Uttar Pradesh","Noida"],["SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre","Alpna Parmar","印度","Gujarat","Surat"],["Cims Hospital","Reena Sharma","印度","Gujarat","Ahmedabad"],["Apollo Hospitals","Ajit Surin","印度","Odisha","Bhubaneswar"],["Bangalore Medical College and Research Institute","Diwakar T Narasimhamurthy","印度","KA","Bengaluru"],["Indraprastha Apollo Hospital","Sundeep Kumar Upadhyaya","印度","National Capital Territory of Delhi","New Delhi"],["IRCCS Policlinico San Matteo","Francesca Bobbio Pallavicini","意大利","Pavia","Pavia"],["Universita Degli Studi di Roma Tor Vergata","Maria Sole Chimenti","意大利","Lazio","roma"],["Azienda Ospedaliero Universitaria Luigi Vanvitelli","Francesco Ciccia","意大利","Campania","Napoli"],["Fondazione Policlinico Universitario A Gemelli IRCCS","Maria Antonietta D Agostino","意大利","Roma","Roma"],["Ospedale San Raffaele","Lorenzo Dagna","意大利","Lombardia","Milano"],["ASST Spedali Civili Brescia","Matteo Filippini","意大利","Lombardia","Brescia"],["Policlinico San Marco","Rosario Foti","意大利","Sicilia","Catania"],["A O Universitaria Senese Ospedale Santa Maria alle Scotte","Bruno Frediani","意大利","Toscana","Siena"],["A.O. Universitaria Ospedali Riuniti di Ancona","Michele Maria Luchetti","意大利","Marche","Ancona"],["Istituto Clinico Humanitas","Carlo Francesco Selmi","意大利","Lombardia","Rozzano"],["Ospedale S. Maria Della Misericordia","Alen Zabotti","意大利","Friuli Venezia Giulia","Udine"],["Dokkyo Medical University Hospital","Kei Ikeda","日本","Totigi","Shimotsuga Gun"],["St. Luke's International Hospital","Kei Ikeda","日本","Tokyo","Tokyo"],["Kyorin University Hospital","Mitsumasa Kishimoto","日本","Tokyo","Tokyo"],["Maeshima Rheumatology Clinic","Keisuke Maeshima","日本","Oita","Oita"],["Kita-harima Medical Center","Kenta Misaki","日本","Aichi","Hyogo"],["National Hospital Organization Kyushu Medical Center","Tomoya Miyamura","日本","Fukuoka","Fukuoka"],["Tohoku University Hospital","Yu Mori","日本","Miyagi","Sendai"],["Nagoya City University Hospital","Akimichi Morita","日本","Aichi","Nagoya City"],["Asahikawa Medical University Hospital","Hiroyoshi Nozaki","日本","Hokkaido Prefecture","Hokkaido"],["Osaka Metropolitan University Hospital","Tadashi Okano","日本","Osaka","Osaka"],["Kansai Medical University Hospital","Yoshio Ozaki","日本","Osaka Prefecture","Hirakata"],["Teikyo University Hospital","Yoshio Ozaki","日本","Tokyo","Itabashi Ku"],["Sanuki Municipal Hospital","Yohei Takeuchi","日本","Kagawa","Sanuki"],["Sasebo Chuo Hospital","Yukitaka Ueki","日本","Nagasaki","Sasebo"],["Mie University Hospital","Keiichi Yamanaka","日本","Mie","Tsu"],["Hospital Universitario Dr Jose Eleuterio Gonzalez","Diana Elsa Flores Alvarado","墨西哥","Nuevo Leon","Monterrey"],["RM Pharma Specialists","Jaime Gonzaga","墨西哥","CDMX","Ciudad de Mexico"],["Centro de Investigacion de Tratamientos Innovadores de Sinaloa","Marco Antonio Maradiaga Cecena","墨西哥","Sinaloa","Culiacan"],["Centro de Alta Especialidad en Reumatologia e Investigacion","Juan Cruz Rizo Rodriguez","墨西哥","San Luis Potosi","San Luis Potosi"],["Grupo Clinico CATEI","Guadalupe Villanueva","墨西哥","Jalisco","Guadalajara"],["Centro Medico del Angel","Beatriz Zazueta","墨西哥","Baja California","Mexicali"],["Specderm Poznanska sp j","Magdalena Bagrowska","波兰","Mexicali","Bialystok"],["Malopolskie Badania Kliniczne Sp z o o","Bogdan Batko","波兰","Warmin sko-Mazurskie","Warminsko-Mazurskie"],["Ambulatorium sp. z o.o.","Anna Bazela Ostromecka","波兰","Warminsko-Mazurskie","Elblag"],["Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna","Pawel Brzewski","波兰","Malopolskie","Krakow"],["Centrum Kliniczno Badawcze","Jan Brzezicki","波兰","Warminsko-Mazurskie","Elblag"],["ClinicMed Daniluk Nowak Spolka Komandytowa","Stefan Daniluk","波兰","Podlaskie","Bialystok"],["Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher","Joanna Dmowska Chalaba","波兰","Mazowieckie","Warsaw"],["MICS Centrum Medyczne Warszawa","Malgorzata Gryka Marton","波兰","Mazowieckie","Warszawa"],["Clinical Research Center sp z o o MEDIC R s k","Maria Jaraczewska Baumann","波兰","Wielkopolskie","Poznan"],["MICS Centrum Medyczne Torun","Slawomir Jeka","波兰","Kujawsko-Pomorskie","Torun"],["Dermed Centrum Medyczne Sp z o o","Andrzej Kaszuba","波兰","Lodzkie","Lodz"],["Pratia MCM Krakow","Mariusz Korkosz","波兰","Lesser Poland Voivodeship","Krakow"],["Etyka Osrodek Badan Klinicznych","Magdalena Krajewska Wlodarczyk","波兰","Warmian-Masurian Voivodeship","Olsztyn"],["NZOZ Lecznica MAK MED S C","Marek Krogulec","波兰","Mazowieckie","Nadarzyn"],["Centrum Medyczne Reuma Park","Ewa Matyska-Piekarska","波兰","Mazowieckie","Warszawa"],["Reumed Zespol Poradni Specjalistycznych Filia nr 1","Marcin Mazurek","波兰","Lubusz","Lublin"],["Centrum Medyczne Oporow","Maria Magdalena Misterska Skora","波兰","Dolnoslaskie","Wroclaw"],["Centrum Medyczne All Med","Grazyna Pulka","波兰","esser Poland Voivodeship","Krakow"],["NZOZ Osteo Medic S C Artur Racewicz i Jerzy Supronik","NZOZ Osteo Medic S C Artur Racewicz i Jerzy Supronik","波兰","Podlaskie","Bialystok"],["Synexus Polska Sp z o o Oddzial we Wroclawiu","Zofia Ruzga","波兰","Lower Silesian Voivodeship","Wroclaw"],["Centrum Medyczne Pratia Gdynia","Anna Sylwestrzak","波兰","Pomorskie","Gdansk"],["Synexus Polska Sp. z o.o. Oddzial w Gdansku","Katarzyna Szudejko","波兰","Pomorskie","Gdansk"],["DermMedica Sp z o o","Jolanta Weglowska","波兰","Lower Silesian Voivodeship","Wroclaw"],["Szpital Uniwersytecki Nr 2 w Bydgoszczy","Rafal Wojciechowski","波兰","Kujawsko-Pomorskie","Bydgoszcz"],["Synexus Polska Sp z o o Oddzial w Warszawie","Magdalena Woroszyl","波兰","Mazowieckie","Warszawa"],["Cardiomed","Irimie Anca Oana","罗马尼亚","CJ","Cluj Napoca"],["Hiperdia Piata Sudului","Georgeta Camelia Badea","罗马尼亚","Bucuresti","Bucuresti"],["Ponderas Academic Hospital","Bogdan Chicos","罗马尼亚","Bucuresti","Bucuresti"],["Centrul Medical Unirea","Alexandra Chitac","罗马尼亚","IS","Iasi"],["SelfMed Clinique","Viorica Crisan","罗马尼亚","TM","Timisoara"],["Medaudio Optica S R L","Razvan Constantin Ionitescu","罗马尼亚","Valcea","Ramnicu Valcea"],["CCBR Clinical Research","Sorica Mustatea","罗马尼亚","Bucuresti","Bucuresti"],["Ecomed Research SRL","Ananu Florentin Vreju","罗马尼亚","Dolj","Craiova"],["HOSP. INFANTA LUISA","Nadia Abdel-Kader Martin","西班牙","AN","Sevilla"],["HOSP. UNIV. FUNDACION ALCORCON","Raquel Almodovar Gonzalez","西班牙","Madrid","Madrid"],["HOSP. VIRGEN DEL ROCIO","Elena Alonso Blanco Morales","西班牙","Andalucia","Sevilla"],["CLINICA GAIAS","Juan Amarelo Ramos","西班牙","A Coruna","Santiago de Compostela"],["HOSP. UNIV. DE BELLVITGE","Laura Berbel Arcobe","西班牙","Barcelona","L Hospitalet de Llobregat"],["HOSP UNIV A CORUNA","Francisco Blanco","西班牙","A Coruna","A Coruna"],["HOSP. UNIV. MARQUES DE VALDECILLA","Ricardo Blanco","西班牙","Cantabria","Santander"],["HOSP. QUIRON SAGRADO CORAZON","Paula Cejas","西班牙","Sevilla","Sevilla"],["HOSP UNIV VALL D HEBRON","Alba Maria Erra Duran","西班牙","Barcelona","Barcelona"],["HOSP REGIONAL UNIV DE MALAGA","Antonio Fernandez Nebro","西班牙","Malaga","Malaga"],["CORPORACIO SANITARI PARC TAULI","Jordi Gratacos","西班牙","Barcelona","Sabadell"],["HOSP. UNIV. 12 DE OCTUBRE","Beatriz Joven","西班牙","Madrid","Madrid"],["HOSP REINA SOFIA","Clementina Lopez Medina","西班牙","AN","Cordoba"],["HOSP. UNIV. INFANTA LEONOR","Maria Teresa Navio","西班牙","Madrid","Madrid"],["HOSP. VIRGEN MACARENA","Jose Javier Perez","西班牙","Sevilla","Sevilla"],["HOSP. CLINICO UNIV. DE SANTIAGO","Eva Perez Pampin","西班牙","GA","Santiago de Compostela"],["HOSP. CLINIC DE BARCELONA","Julio Ramirez","西班牙","CT","Barcelona"],["Saraburi Hospital","Nittayawadee Aeamsaard","泰国","Saraburi Province","Saraburi"],["Rajavithi Hospital","Sungchai Angthararak","泰国","Bangkok","Bangkok"],["Phramongkutklao Hospital","Sumapa Chaiamnuay","泰国","Bangkok","Bangkok"],["Siriraj Hospital","Praveena Chiowchanwisawakit","泰国","Bangkok","Bangkok"],["Songklanagarind hospital","Chutima Seree Aphinan","泰国","Songkhla Province","Songkhla"],["Torbay Hospital-Devon","Tin Aung","英国和北爱尔兰","England","Torquay"],["New Cross Hospital","Nick Barkham","英国和北爱尔兰","West Midlands","Wolverhampton"],["Oxford University Hospitals NHS Foundation Trust","Laura Coates","英国和北爱尔兰","England","Oxford"],["Guys and St Thomas NHS Foundation Trust","Frances Humby","英国和北爱尔兰","Greater London","London"],["Guys and St Thomas NHS Foundation Trust","Hanna Johnsson","英国和北爱尔兰","Scotland","Larbert"],["Chapel Allerton Hospital","Helena Marzo Ortega","英国和北爱尔兰","West Yorkshire","Leeds"],["University Hospitals Dorset NHS Foundation Trust","Marco Massarotti","英国和北爱尔兰","Dorset","Poole"],["Glasgow Royal Infirmary","Iain McInnes","英国和北爱尔兰","Scotland","Glasgow"],["Western General Hospital","Neil McKay","英国和北爱尔兰","Edinburgh","Edinburgh"],["University Hospital Aintree","Jagdish Nair","英国和北爱尔兰","England","Liverpool"],["Haywood Hospital","Jon Packham","英国和北爱尔兰","West Midlands","Staffordshire"],["County Durham and Darlington NHS Foundation Trust","Sanjay Pathare","英国和北爱尔兰","County Durham","Darlington"],["Hereford County Hospital","Sophie Plumb","英国和北爱尔兰","England","Hereford"],["Betsi Cadwaladr University Health Board BCUHB","Subhra Raghuvanshi","英国和北爱尔兰","Borders Region","Wrexham"],["Barnsley Hospital NHS Foundation Trust","Hisham Sharlala","英国和北爱尔兰","England","Barnsley"],["Royal Free London NHS Foundation Trust","Hasan Tahir","英国和北爱尔兰","London Borough of Barnet","Barnet"],["Basingstoke And North Hampshire Hospital","Emma Williams","英国和北爱尔兰","Hampshire","Basingstoke"],["Doncaster and Bassetlaw Hospitals NHS Foundation Trust","Chee Seng Yee","英国和北爱尔兰","South Yorkshire","Doncaster"],["DM Clinical Research","Shaikh Ali","美国","TX","Tomball"],["Advanced Rheumatology of Houston","Tamar Brionez","美国","TX","The Woodlands"],["Clinical Research of West Florida","John Carter","美国","FL","Tampa"],["Arthritis And Osteoporosis Clinic","HS Eugene Fung","美国","TX","waco"],["Rheumatology Associates of Oklahoma","Latisha Heinlen","美国","OK","Oklahoma City"],["Klein And Associates M D P A","Mary Howell","美国","MD","Hagerstown"],["Clinic of Robert Hozman","Robert Hozman","美国","IL","Skokie"],["Altoona Center For Clinical Research","Alan Kivitz","美国","PA","Duncansville"],["Arizona Arthritis and Rheumatology Research PLLC","Nikila Kumar","美国","AZ","Mesa"],["Clinical Research of West Florida","Robert Levin","美国","FL","Clearwater"],["Arthritis and Rheumatism Associates ARA Jonesboro","Leslie McCasland","美国","AR","Jonesboro"],["Swedish Medical Center","Philip Mease","美国","WA","Seattle"],["VA Healthcare System Bay Pines","Priyanka Murali","美国","FL","Bay Pines"],["Joint and Muscle Research Institute","Alireza Nami","美国","NC","Charlotte"],["AARA Clinical Research Lone Star Arthritis and Rheumatology","Ho Bing Oei","美国","TX","Irving"],["Center of Rheumatic Diseases","Kurt Oelke","美国","WI","Glendale"],["Albuquerque Rehabilitation and Rheumatology","Leroy Pacheco","美国","NM","Albuquerque"],["St Paul Rheumatology PA","David Ridley","美国","MN","Eagan"],["Arizona Arthritis and Rheumatology Research PLLC","Nehad Soloman","美国","AZ","Glendale"],["Integral Rheumatology And Immunology Specialists","Guillermo Valenzuela","美国","FL","Plantation"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["复旦大学附属华山医院HIRB","同意","2024-11-19"],["复旦大学附属华山医院伦理审查委员会HIRB","同意","2024-12-26"]]

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: 82 ； 国际: 750 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
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：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
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；