戈利木单抗(Golimumab) - 药物靶点：TNF-α_在研适应症：中轴性脊柱关节炎，溃疡性结肠炎，幼年特发性关节炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-TNF-alpha monoclonal antibody、Golimumab (Genetical Recombination)、Golimumab (genetical recombination) (JAN)

+ [14]

靶点

TNF-α

作用方式

抑制剂

作用机制

TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [4]

在研适应症

中轴性脊柱关节炎溃疡性结肠炎幼年特发性关节炎+ [10]

非在研适应症

1型糖尿病附着点炎炎症+ [5]

原研机构

Janssen Global Services LLC

在研机构

Janssen Research & Development LLCJanssen Pharmaceutical KKJanssen-Cilag International NV

+ [4]

非在研机构

Schering-Plough Corp.

Merck Sharp & Dohme Corp.Centocor, Inc.

+ [2]

权益机构

Celsius Therapeutics, Inc.

Janssen Biotech, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2009-04-24),

强直性脊柱炎银屑病关节炎类风湿关节炎

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

Sequence Code 10217CDR2-L

来源: *****

Sequence Code 34550CDR3-L

来源: *****

Sequence Code 208354L

来源: *****

Sequence Code 1694337H

来源: *****

Sequence Code 13027041CDR2-H

来源: *****

Sequence Code 535237464CDR3-H

来源: *****

Sequence Code 559603504CDR1-L

来源: *****

Sequence Code 1167865419CDR1-H

来源: *****

关联

123

项与戈利木单抗相关的临床试验

NCT07138898

/ Not yet recruiting临床2期IIT

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

开始日期2025-09-01

申办/合作机构

NYU Langone Health

NCT05960578

/ Recruiting临床2期IIT

TRAMP: Tumor Necrosis Factor- α Blockade and AR Inhibition in Men With CRPC

This phase II trial tests how well golimumab and apalutamide work in treating patients with castration resistant prostate cancer. Golimumab is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving golimumab and apalutamide may work better in treating patients with castration-resistant prostate cancer.

开始日期2024-05-23

申办/合作机构

University of Washington

[+1]

NCT05242484

/ Active, not recruiting临床2期

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

开始日期2022-09-19

申办/合作机构

Janssen Research & Development LLC

100 项与戈利木单抗相关的临床结果

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100 项与戈利木单抗相关的转化医学

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100 项与戈利木单抗相关的专利（医药）

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1,647

项与戈利木单抗相关的文献（医药）

2026-03-01·Journal of Stomatology Oral and Maxillofacial Surgery

Refractory oral manifestations of Crohn's disease

Article

作者: Campana, F ; Falguière, A ; Khemis, A ; Reimund, J M ; Amatore, F ; Lan, R

INTRODUCTION:

Persistent oral manifestations of Crohn's disease (CD), despite intestinal remission, remain a therapeutic challenge. This study aimed to describe two such cases and review available literature on management strategies.

CASE REPORTS:

Despite infliximab and methotrexate, the first patient developed progressive oral lesions with only partial improvement under upadacitinib. The second achieved digestive remission under golimumab and successfully controlled oral lesions with intralesional corticosteroids.

DISCUSSION:

A literature review (Pubmed, ScienceDirect; up to January 2025) identified 17 articles involving 75 patients. Oral lesions appeared independently (54 %), concomitantly with digestive disease (20 %), or preceded it (26 %). Therapeutic responses were variable, with limited efficacy of anti-TNF antibodies, immunosuppressants, and corticosteroids. Anti-IL12/23 antibodies showed promising results in isolated cases, while data on anti-IL-23 antibodies and JAK inhibitors remain lacking.

CONCLUSION:

Due to the absence of standardized therapeutic protocols, a personalized, multidisciplinary approach is essential. Further studies are needed to better define effective treatments.

2026-01-01·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Evaluation of anti-drug antibodies against therapeutic monoclonal antibodies and related product in Japanese patients with rheumatoid arthritis and their clinical impact

Article

作者: Yamada, Soichi ; Saito, Yoshiro ; Tsukagoshi, Eri ; Masuoka, Shotaro ; Ishii-Watabe, Akiko ; Shibata, Hiroko ; Hirose, Wataru ; Nanki, Toshihiro ; Kawai, Shinichi ; Nishimura, Kazuko

Biopharmaceuticals are widely used to treat rheumatoid arthritis (RA) due to their high therapeutic efficacy. However, these drugs may elicit immunogenicity and induce the production of anti-drug antibodies (ADA), potentially impacting their efficacy and safety. Therefore, the detection and characterization of ADA in patient samples during clinical development is crucial. However, data regarding biopharmaceutical immunogenicity and associated clinical factors in Japanese patients with RA remain limited. Here, we measured ADA levels in the sera of Japanese patients with RA treated with biopharmaceuticals (infliximab, adalimumab, golimumab, tocilizumab, and etanercept), investigated the clinical factors associated with ADA formation, and examined the effect of ADA on the pharmacological activity of each drug. Although the prevalence of ADA varied among biopharmaceuticals, no apparent neutralizing activity was observed. Among clinical factors, the use of concomitant methotrexate (MTX) influenced ADA prevalence in patients treated with adalimumab and the route of administration was a significant factor in patients treated with tocilizumab. Analyzing the relationship between ADA-positive/negative status and human leukocyte antigen (HLA) revealed that HLA-DRB1*04:01 allele frequency tended to be higher in the anti-etanercept ADA-positive group. The free drug concentration tended to be lower in ADA-positive samples, suggesting that the presence of ADA may have pharmacokinetic implications. Although experimental evaluation of the impact of ADA on drug pharmacological activity in patient samples is typically complex, we developed a method to measure residual drug bioactivity using cell-based assays as an alternative to evaluating the neutralization activity of ADA, and demonstrated the utility of this approach to assess the clinical impact of ADA.

2026-01-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Frequency and Effectiveness of Dose Escalation and De‐Escalation of Biologic Therapy in Inflammatory Bowel Disease: The RAINBOW ‐ IBD Study of ENEIDA

Article

作者: Sesé, Eva ; Pajares, Ramón ; Robledo Andrés, Pilar ; Muñoz, Fernando ; de Francisco, Ruth ; Barreiro‐de Acosta, Manuel ; Gomollón, Fernando ; Navarro‐Llavat, Mercè ; Fernández, Hipólito ; Frago, Santiago ; Suria Bolufer, Carles ; Jaó, Jordina ; Casanova, María José ; Almela, Pedro ; Navas‐López, Victor Manuel ; Vera, Isabel ; Piqueras, Marta ; Giordano, Antonio ; Márquez, Lucía ; Bujanda, Luis ; Rodríguez‐Gutiérrez, Cristina ; Gilabert, Pau ; Bermejo, Fernando ; Martín‐Arranz, M. Dolores ; Martínez Pérez, Teresa ; Valldosera, Gemma ; Mañosa, Miriam ; Mesonero, Francisco ; Rivero, Montserrat ; Ber, Yolanda ; Esteve, María ; Ramos, Laura ; Ricart, Elena ; Sierra‐Ausín, Mónica ; García‐Sepulcre, Mariana Fe ; de Castro, Luisa ; Pérez‐Calle, José Lázaro ; Van Domselaar, Manuel ; Riera, Joan ; Fernández‐Salazar, Luis Ignacio ; García‐López, Santiago ; Guardiola, Jordi ; Rubín de Célix, Cristina ; García‐Alonso, Francisco Javier ; Alcaín, Guillermo ; Rodríguez‐Lago, Iago ; Ginard, Daniel ; Argüelles‐Arias, Federico ; Muñoz‐Villafranca, Carmen ; Domènech, Eugeni ; Ramírez de la Piscina, Patricia ; Fuentes Coronel, Ana ; Martínez‐Flores, Carlos ; Tardillo, Carlos ; Calvet, Xavier ; Nos, Pilar ; Marín‐Jiménez, Ignacio ; Hernández, Luis ; Huguet, José M. ; Taxonera, Carlos ; Buendía Sánchez, Lidia ; Muñoz, Rosa Ana ; Varela, Pilar ; Lucendo, Alfredo J. ; Carpio, Daniel ; Busquets, David ; Ponferrada‐Díaz, Ángel ; Chaparro, María ; Gutiérrez, Ana ; Iglesias, Eva ; Legido Gil, Jesús ; Arias, Lara ; Gisbert, Javier P. ; Lorente, Rufo ; Camps, Blau ; Vega, Pablo

ABSTRACT:

Background:

Real‐world data on dose escalation/de‐escalation in inflammatory bowel disease (IBD) are scarce.

Aims:

To assess the frequency, effectiveness and durability of escalation/de‐escalation of infliximab, adalimumab, golimumab, vedolizumab and ustekinumab in IBD, and to identify factors influencing relapse and drug discontinuation and re‐escalation efficacy.

Methods:

We included patients from the ENEIDA registry of GETECCU who were exposed to biologics and analysed escalations/de‐escalations. We assessed the impact of variables on durability, drug discontinuation and relapse after escalation/de‐escalation.

Results:

Of 19,720 patients on biologics, 5096 (26%) underwent dose escalation. Frequency of escalation per patient‐year was 5% (infliximab), 7% (adalimumab), 7% (golimumab), 10% (vedolizumab) and 12% (ustekinumab). Clinical remission was recaptured in 32%–49% of patients. Durability of escalation (24 months) ranged from 66% to 88%. Drug discontinuation was associated with previous biologic exposure and disease duration (infliximab), monotherapy (adalimumab) and ulcerative colitis (ustekinumab). There were 669 de‐escalations. The frequency per patient‐year was 6%, 9%, 5%, 6% and 3% for infliximab, adalimumab, golimumab, vedolizumab and ustekinumab. Maintenance of remission after de‐escalation was observed in 75%–100%. Durability of de‐escalation (12 months) was 82%–90%. Factors associated with relapse were biologic exposure (infliximab) and age at de‐escalation (adalimumab). Re‐escalation benefited most patients.

Conclusions:

In the long term, some patients with IBD need biologic escalation, which frequently recaptures durable clinical remission. De‐escalation is feasible in some patients. Re‐escalation is generally effective after relapse.

291

项与戈利木单抗相关的新闻（医药）

2025-12-13

·中财网

百奥泰(688177):百奥泰自愿披露关于GOTENFIA（戈利木单抗注射液）获欧洲药品管理局人用药品委员会积极意见

原标题:百奥泰:百奥泰自愿披露关于Gotenfia（戈利木单抗注射液）获欧洲药品管理局人用药品委员会积极意见的公告证券代码：688177 证券简称：百奥泰公告编号：2025-069 百奥泰生物制药股份有限公司 ? Gotenfia 自愿披露关于（戈利木单抗注射液）获欧洲药品管理局人用药品委员会积极意见的公告本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。百奥泰生物制药股份有限公司（以下简称“百奥泰”或“公司”）于近日收到? 了欧洲药品管理局（以下简称“EMA”）的通知，Gotenfia（BAT2506，戈利木单抗注射液）获得EMA人用药品委员会（以下简称“CHMP”）积极意见。 ? CHMP建议欧盟委员会（EC）批准Gotenfia上市，用于治疗类风湿关节炎，幼年特发性关节炎，银屑病关节炎，中轴型脊柱关节炎，溃疡性结肠炎。现将相关情况公告如下：一、药品相关情况（一）药品名称：戈利木单抗注射液 ? （二）商品名称：Gotenfia （三）剂型规格：预灌封注射器：50mg/0.5mL，100mg/1mL （四）适应症：类风湿关节炎，幼年特发性关节炎，银屑病关节炎，中轴型脊柱关节炎，溃疡性结肠炎二、药品其他相关情况 BAT2506是百奥泰根据中国国家药品监督管理局（以下简称“NMPA”）、美国食品药品监督管理局（以下简称“FDA”）、EMA生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。 ? BAT2506（戈利木单抗注射液）的原研药为美国强生公司的Simponi ? ? （欣普尼）。根据强生公司2024年年度报告，Simponi 2024年在全球的销售额为21.90亿美元。截至本公告披露日，BAT2506（戈利木单抗注射液）的上市许可申请已获得NMPA、FDA、巴西国家卫生监督局受理。公司已于全球多区域开展了BAT2506（戈利木单抗）注射液的商业化进程，主要包括：合作公司授权合作区域 STADAArzneimittelAG 欧盟、英国、瑞士以及其他部分欧洲国家 IntasPharmaceuticalsLtd. 美国、加拿大 SteinCares 巴西以及其余拉丁美洲 PharmaparkLLC 俄罗斯和其他独联体国家柬埔寨、印度尼西亚、马来西亚、菲律 Dr.Reddy’sLaboratoriesLtd. 宾、泰国等东南亚市场三、风险提示及对公司影响 ? 本次获得CHMP积极意见，使得Gotenfia有望获得EMA批准并为患者带来新的治疗选择，有望拓展公司国际化市场，进一步提升公司产品的国际影响力，有望对公司长期经营业绩产生积极影响。考虑到医药产品具有高科技、高风险、高附加值的特点，药品的前期研发以及产品从研制、临床试验报批到投产的周期长，易受到技术、审批、政策等多方面因素的影响，未来产品市场竞争形势均存在诸多不确定性，敬请广大投资者谨慎决策，注意投资风险，公司将及时对后续进展情况履行信息披露义务。特此公告。百奥泰生物制药股份有限公司董事会 2025 12 13 年月日中财网

2025-12-13

·YAO资源

12月13日医药新闻

今日国内外医药新闻(2025年12月13日) 国内医药动态 1. 监管与政策 - 医保药品目录更新：2025版国家医保目录新增114种药品(105种谈判新增、7种竞价新增、2种直接调入)，调出29种，目录内药品达3253种。首版商保创新药目录纳入19种高价创新药(含CAR-T、双特异性抗体等)，其中9种为1类新药。(来源：国家医保局，12月9日) - 第十批国家药品集采：62种药品成功入选，覆盖高血压、糖尿病、肿瘤、心脑血管等治疗领域，结果于12月12日在上海揭晓。(来源：抖音，12月12日) - 药品追溯监管：国家医保局推进药品追溯码在医保基金监管应用，已开展试点并下发重复结算疑点数据。(来源：国家医保局，1月) 2. 企业动态 - 人福医药被ST：因累计占用资金127亿元等违规行为，公司及原控股股东、9名高管被处罚3670万元，股票将于12月15日起变更为"ST人福"。(来源：中国经营报，12月13日) - 皓元医药理财：拟使用不超过5亿元闲置募集资金投资保本型金融产品，提高资金效率。(来源：新浪财经，12月12日) - 鲁抗医药定增：推出12亿元定增计划，用于高端制剂车间、生物农药基地及新药研发，以应对行业增速放缓。(来源：界面新闻，12月13日) - 德展健康高管变动：副总经理王曙宾因个人原因离职，公司近期已有多名高管调整。(来源：新浪财经，12月13日) 3. 新药获批与申报 - 诺诚健华佐来曲替尼：12月11日获批上市，用于治疗携带NTRK融合基因的晚期实体瘤，临床ORR达89.1%，可克服第一代TRK抑制剂耐药。(来源：健康界，12月12日) - 中国生物制药库莫西利：全球首个CDK2/4/6抑制剂获批，联合氟维司群治疗HR+/HER2-晚期乳腺癌，中位PFS达16.62个月，降低疾病进展风险64%。(来源：健康界，12月12日) - 健康元玛帕西沙韦：抗流感1类新药获批，针对单纯性甲乙型流感，症状缓解时间比安慰剂缩短27小时。(来源：健康界，12月12日) - 赛诺菲赛菲因：全球首个血友病RNAi疗法在华获批，一年仅需注射6次，用于治疗重型A/B型血友病。(来源：上观新闻，12月12日) - 复宏汉霖斯鲁利单抗：胃癌围手术期适应症NDA获NMPA受理并纳入优先审评，联合化疗用于PD-L1阳性可切除胃癌。(来源：金融界，12月12日) - Novartis琥珀酸瑞波西利：今日获NMPA受理，用于乳腺癌治疗。(来源：网易新闻，12月13日) 国际医药动态 1. 监管审批 - EMA推荐7款新药：人用药品委员会(CHMP)在12月8-11日会议上推荐7种新药上市，同时对部分药物给出否定意见。(来源：EMA官网，12月12日) - FDA今日审批：对Milestone公司CARDAMYST(etripamil)鼻喷雾剂做出最终决定，用于治疗阵发性室上性心动过速。(来源：Investing.com，7月) - FDA 12月重点审批： - lisocabtagene maraleucel：淋巴瘤CAR-T疗法 - gepotidacin/zoliflodacin：淋病治疗药物(12月15日) - lerdalcibep：降胆固醇PCSK9抑制剂 - aficamten：肥厚型心肌病药物 (来源：家庭医生在线等，12月) 2. 产品进展 - 百奥泰戈利木单抗：今日公告获EMA CHMP积极意见，为类风湿关节炎等自身免疫疾病生物制剂。(来源：上交所公告，12月13日) - 默克sotatercept：获CHMP推荐扩大肺动脉高压适应症至WHO功能分级II/III/IV级患者。(来源：默克官网，12月12日) - 辉瑞Tukysa：HER2阳性乳腺癌一线维持治疗III期数据积极，联合曲妥珠单抗和帕捷特可降低35.9%疾病进展风险。(来源：BioSpace，12月11日) - 罗氏giredestrant：口服SERD治疗早期乳腺癌III期数据积极，降低30%侵袭性复发风险。(来源：健康界，(来源：健康界，12月12日) 3. 企业与行业 - 中国创新药出海爆发：2025年对外授权交易总额超1000亿美元，三大里程碑交易： - 恒瑞-GSK：125亿美元(首付款) - 信达-武田：114亿美元 - 三活制药-辉瑞：12.5亿美元 (来源：PharmiWeb，12月11日) - GSK高管观点：即将卸任CEO Emma Walmsley称美国是最佳投资地，对英国制药业构成打击。(来源：独立报，12月11日) - 辉瑞并购余力：收购Metsera后仍有约60亿美元业务拓展空间，CEO表示交易未止。(来源：BioSpace，12月10日) 今日重点新药速览药品名称公司适应症特点/进展佐来曲替尼诺诚健华 NTRK融合实体瘤 ORR 89.1%，克服耐药库莫西利中国生物制药 HR+/HER2-乳腺癌全球首创CDK2/4/6抑制剂玛帕西沙韦健康元单纯性流感症状缓解快27小时芬妥司兰赛诺菲血友病A/B RNAi疗�[__LINK_ICON]��，年注射≤6次戈利木单抗百奥泰自身免疫疾病[__LINK_ICON] 获EMA积极意见注：部分信息截至北京时间2025年12月13日12:00，国际新闻因时差可能包含12月12日晚至13日凌晨事件。

细胞疗法上市批准申请上市优先审批免疫疗法

2025-12-12

·EndPoints

CHMP calls to reject Anavex's Alzheimer’s pill over impurities, side effects and weak efficacy

As part of a batch of recommendations issued Friday, the European Medicines Agency’s human medicines committee (CHMP) recommended rejecting Anavex’s Alzheimer’s disease drug, issuing a scathing review of the pill’s safety and efficacy issues. The committee said it was concerned that the pill, called blarcamesine, could contain cancer-causing impurities. In addition, its main clinical study failed to meet its objective, and a “high proportion of patients” stopped taking the drug because of central nervous system side effects. Last month Anavex said it planned to request a reexamination of blarcamesine from the European regulators, after CHMP warned a negative opinion was likely. Anavex has 15 days to file for reexamination. As part of Friday’s package of actions, the committee also recommended five new medicines and 10 label expansions. GSK secured a positive opinion for its RSV vaccine Arexvy to be expanded to patients 18 years or older, rather than its previous approval for just people aged 50 or over. Arexvy was approved by the European Medicines Agency in June 2023. This brings the RSV vaccine to an equal footing with its competitors: Pfizer’s Abrysvo and Moderna’s mResvia, which have both already been approved for adults aged 18 or older. GSK’s Exdensur also got a positive CHMP opinion for adults and adolescents 12 years and older with severe eosinophilic asthma as well as for severe chronic rhinosinusitis with nasal polyps. Depemokimab is currently under review by the FDA, with a PDUFA date of Dec. 16. CHMP gave a positive opinion for four other new medicines: CHMP recommended nine other label expansions:

上市批准疫苗加速审批

100 项与戈利木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04358	戈利木单抗	L04AB06	DB06674

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
中轴性脊柱关节炎	欧盟	Janssen-Cilag International NV	2009-10-01
中轴性脊柱关节炎	冰岛	Janssen-Cilag International NV	2009-10-01
中轴性脊柱关节炎	列支敦士登	Janssen-Cilag International NV	2009-10-01
中轴性脊柱关节炎	挪威	Janssen-Cilag International NV	2009-10-01
溃疡性结肠炎	欧盟	Janssen-Cilag International NV	2009-10-01
溃疡性结肠炎	冰岛	Janssen-Cilag International NV	2009-10-01
溃疡性结肠炎	列支敦士登	Janssen-Cilag International NV	2009-10-01
溃疡性结肠炎	挪威	Janssen-Cilag International NV	2009-10-01
幼年特发性关节炎	欧盟	Janssen-Cilag International NV	2009-10-01
幼年特发性关节炎	冰岛	Janssen-Cilag International NV	2009-10-01
幼年特发性关节炎	列支敦士登	Janssen-Cilag International NV	2009-10-01
幼年特发性关节炎	挪威	Janssen-Cilag International NV	2009-10-01
非放射性轴性脊柱关节炎	欧盟	Janssen-Cilag International NV	2009-10-01
非放射性轴性脊柱关节炎	冰岛	Janssen-Cilag International NV	2009-10-01
非放射性轴性脊柱关节炎	列支敦士登	Janssen-Cilag International NV	2009-10-01
非放射性轴性脊柱关节炎	挪威	Janssen-Cilag International NV	2009-10-01
多关节型幼年特发性关节炎	欧盟	Janssen-Cilag International NV	2009-10-01
多关节型幼年特发性关节炎	冰岛	Janssen-Cilag International NV	2009-10-01
多关节型幼年特发性关节炎	列支敦士登	Janssen-Cilag International NV	2009-10-01
多关节型幼年特发性关节炎	挪威	Janssen-Cilag International NV	2009-10-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
炎症	临床3期	比利时	Merck Sharp & Dohme Corp.	2017-11-08
涎腺多形性腺瘤	临床3期	英国	Janssen Pharmaceutica NV	2015-10-27
附着点炎	临床3期	葡萄牙	Merck Sharp & Dohme LLC	2014-08-01
脊椎关节炎	临床3期	比利时	Janssen Biologics BV	2012-03-13
多发性关节炎	临床3期	美国	Janssen Research & Development LLC	2010-12-01
多发性关节炎	临床3期	美国	Schering-Plough Corp.	2010-12-01
多发性关节炎	临床3期	奥地利	Janssen Research & Development LLC	2010-12-01
多发性关节炎	临床3期	奥地利	Schering-Plough Corp.	2010-12-01
多发性关节炎	临床3期	比利时	Janssen Research & Development LLC	2010-12-01
多发性关节炎	临床3期	比利时	Schering-Plough Corp.	2010-12-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04108468 (GOLMePsA, CTgov)	临床3期	涎腺多形性腺瘤 \| 银屑病关节炎	84	Methotrexate (Methotrexate)	積繭築獵衊顧鬱觸獵鏇(獵構遞製壓簾製膚選襯) = 餘獵獵衊遞襯廠鏇範齋艱鹹餘淵鑰鹹壓繭觸衊 (遞壓蓋願鹹窪範鹹夢願, 1.32) 更多	-	2025-12-02
				Golimumab+Methotrexate (Golimumab & Methotrexate)	積繭築獵衊顧鬱觸獵鏇(獵構遞製壓簾製膚選襯) = 憲鹹範構鏇遞糧齋膚夢艱鹹餘淵鑰鹹壓繭觸衊 (遞壓蓋願鹹窪範鹹夢願, 1.38) 更多
NCT03596645 (PURSUIT 2, CTgov)	临床3期	溃疡性结肠炎	84	Golimumab (Group 1: Golimumab)	簾壓繭糧獵餘製壓簾鑰 = 蓋觸範夢製襯積壓願觸窪積獵膚糧築構壓廠淵 (簾網鑰簾選觸艱簾窪窪, 廠餘顧鏇壓顧餘餘蓋醖 ~ 鏇獵築構願夢製鏇鏇願) 更多	-	2025-11-14
				Infliximab (Group 2: Infliximab)	鬱淵網築鹽淵製憲齋憲(簾膚醖齋鬱壓遞繭遞壓) = 網構糧蓋製積餘蓋夢齋鹽廠獵選鹽夢夢遞糧獵 (憲憲構鬱艱糧製顧構積, 觸觸鹹製齋糧壓膚鬱淵 ~ 觸鏇蓋築膚醖衊願鏇鹽) 更多
NCT03729349 (Pubmed \| Patient Prefer Adherence)	N/A	类风湿关节炎	215	High adherence to golimumab treatment	顧淵壓鑰窪蓋廠鹹鏇憲(膚鏇鬱窪鬱積淵範簾醖) = 鬱憲憲艱顧壓構遞鏇糧簾夢獵衊襯廠願願觸積 (廠鏇鑰齋範獵築廠鬱鏇 ) 更多	不佳	2025-06-01
				Low adherence to golimumab treatment	顧淵壓鑰窪蓋廠鹹鏇憲(膚鏇鬱窪鬱積淵範簾醖) = 繭艱艱廠顧獵鏇膚選膚簾夢獵衊襯廠願願觸積 (廠鏇鑰齋範獵築廠鬱鏇 ) 更多
NCT03270501 (GO-GUT, CTgov)	临床3期	炎症 \| 中轴性脊柱关节炎	64	Golimumab	範醖壓簾壓鑰鏇積鏇觸 = 壓憲膚膚鏇襯鹽淵淵簾獵鑰鏇夢鬱簾夢鬱鏇選 (衊網觸簾壓壓繭糧壓廠, 簾選鹽積窪膚糧窪淵淵 ~ 製窪鬱淵選餘醖衊網製) 更多	-	2025-02-11
NCT05842213 (ALVOFLEX, ACR2024 \| NEWS)	-	类风湿关节炎	502	戈利木单抗-AVT05	憲簾壓窪遞選廠餘鹹觸(窪淵願鹹窪衊鏇醖襯衊) = Clinical results have reached the endpoint 繭糧鏇遞繭構齋簾齋鹹 (願蓋廠窪鏇鏇築鑰窪衊 )	相似	2024-04-24
				戈利木单抗
NCT02277444 (GO-VIVA, ACR2023)	临床3期	多关节型幼年特发性关节炎	127	Golimumab 80 mg/m2 IV q8w	構醖觸願膚襯簾觸膚鹹(製憲顧網膚獵夢鹹襯蓋) = AEs and SAEs were reported in 92.1% and 19.7% of pts, respectively. One death (septic shock) occurred. 構獵壓構願鹽鬱膚積顧 (範鏇鏇鹽繭網夢鏇鏇廠 )	积极	2023-11-12
				Placebo
NCT00488631 (PURSUIT-M, Pubmed \| Crohns Colitis 360)	临床3期	活动性重度溃疡性结肠炎维持	1,228	Golimumab 50 mg	願餘醖簾廠簾製簾構膚(襯艱廠製衊鑰遞蓋鬱鏇) = 憲蓋簾餘製鬱廠獵網築鬱窪鑰廠選選獵淵蓋鹽 (構夢構繭選範鬱觸鬱憲 )	积极	2023-07-01
				Golimumab 100 mg	願餘醖簾廠簾製簾構膚(襯艱廠製衊鑰遞蓋鬱鏇) = 衊艱觸醖網蓋獵積選齋鬱窪鑰廠選選獵淵蓋鹽 (構夢構繭選範鬱觸鬱憲 )
BIOBADABRASIL (EULAR2023)	N/A	类风湿关节炎	227	Certolizumab	鑰齋網製顧糧餘夢積衊(選襯醖襯鹹鑰艱範遞壓): hazard ratio = 1.58 (95% CI, 0.96 ~ 2.6), P-Value = 0.069	不佳	2023-05-31
				Golimumab
NCT02728934 (Pubmed)	临床4期	类风湿关节炎	1,270	IV golimumab	繭糧觸顧獵顧網繭廠顧(鬱遞壓繭鹹淵艱鬱構餘) = 顧繭蓋醖襯衊餘襯艱鑰淵選積糧衊鬱壓蓋獵廠 (窪衊積鬱鏇憲獵選鏇構 ) 更多	-	2023-02-23
				Infliximab	繭糧觸顧獵顧網繭廠顧(鬱遞壓繭鹹淵艱鬱構餘) = 網積鬱繭遞積鹽壓構範淵選積糧衊鬱壓蓋獵廠 (窪衊積鬱鏇憲獵選鏇構 ) 更多
NCT03662542 (VEGA, Pubmed)	临床2期	溃疡性结肠炎	214	Guselkumab plus golimumab combination therapy	廠繭選簾鑰觸糧窪網鹽(齋積淵範遞襯遞積獵壓) = 選繭壓鑰壓衊鑰窪願顧鑰齋憲襯鹽選遞壓鹹顧 (餘築鹹糧餘淵膚憲顧鹽 )	-	2023-02-01
				Golimumab monotherapy	廠繭選簾鑰觸糧窪網鹽(齋積淵範遞襯遞積獵壓) = 顧鹽鑰齋醖範鬱壓鬱齋鑰齋憲襯鹽選遞壓鹹顧 (餘築鹹糧餘淵膚憲顧鹽 )