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Guselkumab 和 Golimumab 联合治疗活动性银屑病关节炎患者的研究 (AFFINITY)

2026年6月25日 更新者：Janssen Research & Development, LLC

一项 2a 期、多中心、随机、双盲研究，评估皮下给予 Guselkumab 和 Golimumab 联合治疗对活动性银屑病关节炎患者的疗效和安全性

本研究的目的是通过评估 guselkumab 加戈利木单抗联合治疗对活动性银屑病关节炎 (PsA) 和对既往抗肿瘤坏死因子-α（抗 TNF-α）疗法反应不足 (IR) 的参与者的疗效与 guselkumab 单药治疗相比的临床反应。

研究概览

地位

完全的

条件

干预/治疗

详细说明

PsA 是一种慢性炎症性多方面疾病，影响周围和轴向关节、软组织和皮肤。 Guselkumab 是一种针对白介素 (IL)-23 的 p19 亚基的全人单克隆抗体 (mAb)，阻断细胞外 IL-23 与细胞表面 IL-23 受体的结合，抑制 IL-23 特异性细胞内信号传导，随后激活和细胞因子的产生。 Golimumab 是一种全人源抗 TNF-α 单克隆抗体，它以高亲和力结合 TNF-α，阻止与其受体结合，从而抑制 TNF-α 的生物活性并导致炎性细胞因子的产生或活性受限，从而提供治疗作用有益于各种慢性炎症性疾病，包括 PsA。 该研究将包括筛选阶段（最多 6 周）、第 0 周至第 24 周的双盲阶段，其中包括积极治疗阶段和主要疗效访问（第 24 周），以及第 24 周至第 24 周的安全随访阶段第 36 周。 关键安全评估将包括不良事件 (AE)、临床实验室安全测试（血液学和化学）、生命体征、注射部位和超敏反应监测以及活动性结核病 (TB) 的早期检测。 研究的总持续时间长达 42 周。

研究类型

介入性

注册 (实际的)

91

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Frederiksberg、丹麦、2000
        • Frederiksberg Hospital
      • Glostrup Municipality、丹麦、2600
        • Rigshospitalet Glostrup
      • Køge、丹麦、4600
        • Køge Sygehus Region Sjaelland
      • Silkeborg、丹麦、8600
        • Silkeborg Hospital
      • Vejle、丹麦、7100
        • Vejle Sygehus
  • 乌克兰
      • Kharkiv、乌克兰、61039
        • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
      • Kharkiv、乌克兰、61204
        • Municipal Institution Regional hospital-center of emergency care and disasters medicine
      • Kyiv、乌克兰、03049
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv、乌克兰、03680
        • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
      • Kyiv、乌克兰、03037
        • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
      • Kyiv、乌克兰、04107
        • Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
      • Poltava、乌克兰、36011
        • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
      • Ternopil、乌克兰、46002
        • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
      • Uzhhorod、乌克兰、88000
        • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
      • Vinnytsia、乌克兰、21009
        • Health Clinic Limited Liability Company
      • Zaporizhzhya、乌克兰、69600
        • Medical Center LLC 'Modern Clinic'
  • 俄罗斯
      • Kemerovo、俄罗斯、650000
        • Kemerovo State Medical University
      • Kemerovo、俄罗斯、650070
        • LLL Medical Center Revma-Med
      • Korolyov、俄罗斯、141060
        • LLC Family Outpatient Clinic # 4
      • Moscow、俄罗斯、129110
        • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
      • Orenburg、俄罗斯、460000
        • Orenburg State Medical Academy
      • Rostov-on-Don、俄罗斯、344007
        • Rostov Regional Clinical Dermatovenerological Dispensary
      • Ryazan、俄罗斯、390046
        • Ryazan Regional Clinical Dermatovenerological Dispensary
      • Saint Petersburg、俄罗斯、194156
        • X7 Clinical Research Company Limited
      • Smolensk、俄罗斯、214025
        • Smolensk regional hospital on Smolensk railway station
      • Ufa、俄罗斯、450005
        • Republican Clinical Hospital - G.G. Kuvatov
      • Yaroslavl、俄罗斯、150007
        • Clinical Hospital #3
  • 匈牙利
      • Budapest、匈牙利、1036
        • Obudai Egeszsegugyi Centrum Kft
      • Gyula、匈牙利、5700
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Székesfehérvár、匈牙利、8000
        • Complex Rendelo Med Zrt
      • Veszprém、匈牙利、8200
        • Vital Medical Center
  • 意大利
      • Cagliari、意大利、09124
        • Azienda Ospedaliero-Universitaria di Cagliari
      • Milan、意大利、20132
        • Ospedale San Raffaele
      • Milan、意大利、20122
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
      • Pavia、意大利、27100
        • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
      • Reggio Emilia、意大利、42123
        • Arcispedale Santa Maria Nuova - IRCCS
      • Roma、意大利、00168
        • Policlinico Universitario Agostino Gemelli
      • Roma、意大利、00133
        • A.O.U.Policlinico Tor Vergata
      • Rome、意大利、00128
        • Università Campus Biomedico di Roma
      • Torino、意大利、10128
        • AO Ordine Mauriziano
  • 法国
      • Le Mans、法国、72037
        • Centre Hospitalier Le Mans
      • Toulouse、法国、31059
        • Hopital Larrey CHU de Toulouse
      • Tours、法国、37044
        • CHU Trousseau - Service de Rhumatologie
  • 波兰
      • Elblag、波兰、82-300
        • Centrum Kliniczno Badawcze
      • Lodz、波兰、90-242
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Nadarzyn、波兰、05-830
        • NZOZ Lecznica MAK MED S C
      • Poznan、波兰、61 113
        • Centrum Medyczne
      • Warsaw、波兰、00-874
        • Medycyna Kliniczna
      • Warsaw、波兰、03 291
        • Centrum Medyczne AMED Targowek
      • Wroclaw、波兰、51 685
        • WroMedica I Bielicka A Strzalkowska s c
  • 瑞典
      • Malmö、瑞典、205 02
        • Skånes universitetssjukhus
      • Solna、瑞典、171 76
        • Karolinska Universitetssjukhuset Solna
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85032
        • Arizona Arthritis and Rheumatology Research PLLC
      • Phoenix、Arizona、美国、85037
        • Arizona Arthritis and Rheumatology Research PLLC 1
    • Arkansas
      • Searcy、Arkansas、美国、72143
        • Unity Health-White County Medical Center
    • Florida
      • Avon Park、Florida、美国、33825
        • HARAC Research Corp
      • Bay Pines、Florida、美国、33744
        • Bay Pines VA Healthcare System
      • DeBary、Florida、美国、32713
        • Omega Research Consultants
      • Miami、Florida、美国、33136
        • South Coast Research Center
      • Ocoee、Florida、美国、34761
        • Advanced Clinical Research of Orlando
      • Ormond Beach、Florida、美国、32174
        • Millennium Research
    • Georgia
      • Marietta、Georgia、美国、30060
        • Atlanta Research Center for Rheumatology
    • Michigan
      • Lansing、Michigan、美国、48911
        • Great Lakes Center of Rheumatology
    • Missouri
      • Springfield、Missouri、美国、65807
        • Clinvest
    • New York
      • Brooklyn、New York、美国、11201
        • NYU Langone Ambulatory Care Brooklyn Heights
      • New York、New York、美国、10016
        • NYU School of Medicine
      • Rochester、New York、美国、14642
        • University of Rochester
      • The Bronx、New York、美国、10461
        • Jacobi Medical Center
    • Ohio
      • Vandalia、Ohio、美国、45377
        • STAT Research, Inc.
    • Texas
      • Plano、Texas、美国、75024
        • Trinity Universal Research Associates, LLC
      • Tomball、Texas、美国、77375
        • DM Clinical Research
    • Washington
      • Seattle、Washington、美国、98122
        • Swedish Medical Center
  • 西班牙
      • A Coruña、西班牙、15006
        • Hosp Univ A Coruna
      • Barcelona、西班牙、08916
        • Hosp. Univ. Germans Trias I Pujol
      • Bilbao、西班牙、48013
        • Hosp. Univ. de Basurto
      • Córdoba、西班牙、14004
        • Hosp Reina Sofia
      • Madrid、西班牙、28041
        • Hosp. Univ. 12 de Octubre
      • Sabadell、西班牙、08208
        • Corporacio Sanitari Parc Tauli
      • Santiago de Compostela、西班牙、15706
        • Hosp. Clinico Univ. de Santiago
      • Seville、西班牙、41009
        • Hosp. Virgen Macarena
      • Seville、西班牙、41014
        • Hosp. Ntra. Sra. de Valme
      • Seville、西班牙、41010
        • Hosp. Infanta Luisa

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 在首次实施研究干预之前被诊断为银屑病关节炎 (PsA) 大于或等于 (>=) 6 个月，并且在筛选时符合 PsA 分类标准 (CASPAR)
  • 患有活动性 PsA，定义为在筛选时和基线时至少有 3 个肿胀关节和至少 3 个压痛关节
  • 至少具有以下 PsA 亚型中的一种：远端指间关节受累、多关节关节炎且无类风湿结节、关节炎 mutilans、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，至少有一块直径 >=2 厘米 (cm) 的银屑病斑块或与银屑病一致的指甲变化
  • 对抗肿瘤坏死因子-α（抗-TNF-α）治疗反应不足（IR），定义为尽管使用 1 种或 2 种既往抗 TNF-α 药物和以下药物治疗但仍存在活动性 PsA ： 一种。在至少 12 周的依那西普、阿达木单抗或赛妥珠单抗聚乙二醇治疗后，或至少 14 周的英夫利昔单抗治疗后，治疗医师在参与者病史中记录的 1 种或 2 种既往抗 TNF-α 疗法缺乏益处，或这 4 种疗法中的任何生物仿制药。 记录在案的益处不足可能包括关节计数、身体机能或疾病活动度改善不足； b. 最后一次抗 TNF-α 治疗剂量必须在首次研究干预给药前超过药物的 5 个半衰期（清除期）

排除标准：

  • 患有其他可能混淆 guselkumab 和/或 golimumab 治疗益处评估的炎症性疾病，包括但不限于类风湿性关节炎 (RA)、强直性脊柱炎 (AS)、非放射学中轴​​型脊柱关节炎 (nr AxSpA)、系统性红斑狼疮或莱姆病疾病
  • 已知对任何生物药物不耐受或过敏，或已知对小鼠、嵌合或人类蛋白质、单克隆抗体 (mAb) 或抗体片段过敏或有临床意义的反应
  • 既往接受过戈利木单抗或古塞库单抗治疗，或治疗医师在参与者病史中记录了对既往抗 TNF-α 治疗的不耐受
  • 已接受超过 2 种先前的抗 TNF-α 药物（或生物仿制药）
  • 阳性人类免疫缺陷病毒 (HIV) 抗体测试

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：第 1 组：Guselkumab 和戈利木单抗
参与者将接受皮下 (SC) guselkumab 和 golimumab。
药品：古塞库单抗
Guselkumab 将作为皮下注射给药。
其他名称：
  • CNTO1959
  • TREMFYA
药品：戈利木单抗
Golimumab 将作为 SC 注射给药。
其他名称：
  • 辛波尼
  • CNTO148
有源比较器：第 2 组：Guselkumab 和安慰剂
参与者将接受 SC guselkumab 和安慰剂。
药品：古塞库单抗
Guselkumab 将作为皮下注射给药。
其他名称：
  • CNTO1959
  • TREMFYA
药品：安慰剂
安慰剂将作为 SC 注射给药。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24
大体时间：Week 24
MDA was a measure that defines a satisfactory state of disease activity that includes 5 domains of psoriatic arthritis (PsA) (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of the following 7 criteria at that visit: Tender joint count (68 joints) <=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index (PASI) <=1, Patient's Assessment of Pain <=15 on a 100-unit visual analog scale (VAS), Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, Disability Index of the Health Assessment Questionnaire (HAQ-DI) score <=0.5, and Tender entheseal points <= 1 (Leeds Enthesitis Index [LEI] score <= 1).
Week 24

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 24
大体时间：Week 24
ACR 50 response was defined as greater than or equal to (>=) 50% improvement from baseline in both swollen joint (66 joints) and tender joint counts (68 joints) and >=50% improvement from baseline in >=3 of 5 assessments: Physician global assessment of disease activity (0 to 100 millimeters [mm] VAS [0=no arthritis activity and 100=extremely active arthritis]), Patient global assessment of disease activity (arthritis) (100 mm VAS [0 = no limitation of normal activities; 100 = very poor]), Patient's global assessment of pain (100 mm VAS [0 = no pain; 100 = most severe pain]), patient's assessment of physical function measured by HAQ-DI (20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and high-sensitivity C-reactive protein (hsCRP).
Week 24
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 16
大体时间：Week 16
MDA was a measure that defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of the following 7 criteria at that visit: Tender joint count (68 joints) <=1, Swollen joint count (66 joints) <=1, PASI <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI score <= 1).
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 Among Participants With >= 3% Body Surface Area (BSA) Psoriatic Involvement and an Investigator Global Assessment (IGA) Score of >=2 (Mild) at Baseline
大体时间：Week 24
PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: head and neck, trunk (including axillae and groin), upper extremities, and lower extremities (included buttocks). Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 to 100% involvement), and erythema, induration and scaling, each rated on a scale of 0 to 4, that was none to maximum severity. PASI produces a numeric score range from 0 (no psoriasis) to 72 (worst condition). Higher scores indicated more severe disease.
Week 24
Percentage of Participants Who Achieved PASI 100 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
大体时间：Week 24
PASI 100 response was defined as 100% reduction in PASI relative to baseline. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: head and neck, trunk (including axillae and groin), upper extremities, and lower extremities (included buttocks). Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 to 100% involvement), and erythema, induration and scaling, each rated on a scale of 0 to 4, that was none to maximum severity. PASI produces a numeric score range from 0 (no psoriasis) to 72 (worst condition). Higher scores indicated more severe disease.
Week 24
Percentage of Participants With an IGA-psoriasis Response at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
大体时间：Week 24
IGA psoriasis response was defined as an IGA psoriasis score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions were graded for induration, erythema, and scaling each using a 5 point scale: clear (0), minimal (1), mild (2), moderate (3), and severe (4). The IGA score of psoriasis was based upon the average of induration, erythema, and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
大体时间：Baseline (Week 0), Week 24
Change from baseline in HAQ-DI score was a measure of the change in the physical function. It consists of a 20-questions instrument that assesses the degree of difficulty a person had in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0 = no difficulty to 3= inability to perform a task. Scores on each task were summed and averaged to provide an overall HAQ-DI total score ranging from 0 (least difficulty) to 3 (extreme difficulty). Lower scores indicated better functioning. Negative change from baseline indicated improvement of physical function.
Baseline (Week 0), Week 24
Percentage of Participants Who Had Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
大体时间：Week 24
Enthesitis assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of tenderness by applying local pressure to the following enthesis sites: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. Each site was scored as 1 if tenderness was present or 0 if tenderness was absent. The enthesitis index score was a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Higher score indicated more sites with tenderness. A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI >0.
Week 24
Percentage of Participants Who Achieved Resolution of Dactylitis Response at Week 24 Among the Participants With Dactylitis at Baseline
大体时间：Week 24
Dactylitis was characterized by swelling in both hands and feet. The severity of dactylitis was scored on a scale from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results for each digit summed to produce final dactylitis score which was from 0 to 60. Higher score indicates more severe dactylitis. Dactylitis count was derived based on dactylitis score, each score was recorded to 0 or 1 from 0 to 3, where any score >0 was recorded as 1. For resolution of dactylitis, it was defined as participants who had a dactylitis score greater than 0 at baseline and a score of 0 at the analysis visit.
Week 24
Change From Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24
大体时间：Baseline (Week 0), Week 24
SF-36 was a multi-domain instrument with 36 items to evaluate health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health). The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Domains 1 to 4 primarily contribute to the PCS score of the SF-36. Domains 5-8 primarily contributes to the MCS score of the SF-36. Each of the 8 domain scores and the component summary score ranged from 0=worst to 100=best. Higher scores represent better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Baseline (Week 0), Week 24
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
大体时间：From Week 0 up to Week 36
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were any AE occurred at or after the initial administration of study intervention through the day of last dose plus 16 weeks.
From Week 0 up to Week 36
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
大体时间：From Week 0 up to Week 36
SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect in the offspring of a participant, or was an important medical event. TESAEs were any SAE occurred at or after the initial administration of study intervention through the day of last dose plus 16 weeks.
From Week 0 up to Week 36
Percentage of Participants With Reasonably Related Adverse Events (AEs)
大体时间：From Week 0 up to Week 36
Percentage of participants with reasonably related AEs was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. AE reasonably related to guselkumab or golimumab were defined as AEs classified by the investigator as related to study agent.
From Week 0 up to Week 36
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
大体时间：From Week 0 to Week 20
Percentage of participants with AEs leading to discontinuation of study intervention was reported. AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
From Week 0 to Week 20
Percentage of Participants With Infections
大体时间：From Week 0 up to Week 36
Percentage of participants with infections was reported. Investigators evaluate participants for any signs or symptoms of infection. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product.
From Week 0 up to Week 36
Percentage of Participants With Injection-site Reactions
大体时间：From Week 0 up to Week 36
Percentage of participants with injection-site reaction was reported. A study intervention injection-site reaction was any adverse reaction at a subcutaneous study intervention injection-site. The injection sites were evaluated for reactions, and any injection-site reaction was recorded as an AE. Injection site reactions were significant bruising, erythema, hemorrhage, irritation, pain, and pruritus.
From Week 0 up to Week 36
Group 1: Guselkumab Plus Golimumab - Serum Concentration of Golimumab
大体时间：Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Serum concentration of golimumab was reported.
Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Serum Concentration of Guselkumab
大体时间：Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Serum concentration of guselkumab was reported.
Weeks 0, 4, 8, 12, 16, 20, 24, and 36
Percentage of Participants With Anti-Guselkumab Antibodies
大体时间：From Week 0 up to Week 36
Percentage of participants with anti-guselkumab antibodies was reported.
From Week 0 up to Week 36
Percentage of Participants With Anti-Golimumab Antibodies
大体时间：From Week 0 up to Week 36
Percentage of participants with anti-golimumab antibodies were reported.
From Week 0 up to Week 36

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

调查人员

  • 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月25日

初级完成 (实际的)

2024年5月14日

研究完成 (实际的)

2024年8月6日

研究注册日期

首次提交

2021年9月6日

首先提交符合 QC 标准的

2021年9月28日

首次发布 (实际的)

2021年10月8日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年6月25日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CR109054
  • 2021-002012-31 (EudraCT编号)
  • CNTO1959PSA2003 (其他标识符：Janssen Research & Development, LLC)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

强生旗下杨森制药公司的数据共享政策可在 www.janssen.com/clinical-trials/transparency 获取。 如本网站所述，可以通过耶鲁大学开放数据访问 (YODA) 项目网站 yoda.yale.edu 提交访问研究数据的请求

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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