此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)

2019年5月20日 更新者：Novartis Pharmaceuticals

A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

460

阶段

  • 第三阶段

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

  • 以色列
      • Ashkelon、以色列、78278
        • Novartis Investigative Site
      • Haifa、以色列、3339419
        • Novartis Investigative Site
      • Ramat Gan、以色列、5265601
        • Novartis Investigative Site
      • Tel Aviv、以色列、6423906
        • Novartis Investigative Site
  • 俄罗斯联邦
      • Ekaterinburg、俄罗斯联邦、620109
        • Novartis Investigative Site
      • Ekaterinburg、俄罗斯联邦、620028
        • Novartis Investigative Site
      • Kemerovo、俄罗斯联邦、650029
        • Novartis Investigative Site
      • Moscow、俄罗斯联邦、115522
        • Novartis Investigative Site
      • St Petersburg、俄罗斯联邦、190068
        • Novartis Investigative Site
      • Yaroslavl、俄罗斯联邦、150003
        • Novartis Investigative Site
  • 保加利亚
      • Pleven、保加利亚、5800
        • Novartis Investigative Site
      • Sofia、保加利亚、1612
        • Novartis Investigative Site
    • Gabrovo
      • Sevlievo、Gabrovo、保加利亚、5400
        • Novartis Investigative Site
  • 加拿大
    • Newfoundland and Labrador
      • St. John's、Newfoundland and Labrador、加拿大、A1C 5B8
        • Novartis Investigative Site
      • St. John's、Newfoundland and Labrador、加拿大、A1A 5E8
        • Novartis Investigative Site
    • Ontario
      • Newmarket、Ontario、加拿大、L3Y 3R7
        • Novartis Investigative Site
      • Waterloo、Ontario、加拿大、N2J 1C4
        • Novartis Investigative Site
    • Quebec
      • Trois-Rivieres、Quebec、加拿大、G8Z 1Y2
        • Novartis Investigative Site
  • 巴西
    • Rio Grande Do Sul
      • Porto Alegre、Rio Grande Do Sul、巴西、90610-000
        • Novartis Investigative Site
    • SP
      • Sao Paulo、SP、巴西、04023-900
        • Novartis Investigative Site
      • Sao Paulo、SP、巴西、04266 010
        • Novartis Investigative Site
  • 德国
      • Aachen、德国、52064
        • Novartis Investigative Site
      • Erlangen、德国、91054
        • Novartis Investigative Site
      • Erlangen、德国、91056
        • Novartis Investigative Site
      • Gommern、德国、39245
        • Novartis Investigative Site
      • Hamburg、德国、22415
        • Novartis Investigative Site
      • Hildesheim、德国、31134
        • Novartis Investigative Site
      • Koeln、德国、50937
        • Novartis Investigative Site
      • Leipzig、德国、04103
        • Novartis Investigative Site
      • Nürnberg、德国、90429
        • Novartis Investigative Site
      • Ratingen、德国、40878
        • Novartis Investigative Site
      • Zerbst、德国、39261
        • Novartis Investigative Site
  • 意大利
    • CT
      • Catania、CT、意大利、95100
        • Novartis Investigative Site
    • PO
      • Prato、PO、意大利、59100
        • Novartis Investigative Site
    • SI
      • Siena、SI、意大利、53100
        • Novartis Investigative Site
    • VR
      • Verona、VR、意大利、37134
        • Novartis Investigative Site
  • 捷克语
    • Czech Republic
      • Bruntal、Czech Republic、捷克语、792 01
        • Novartis Investigative Site
      • Uherske Hradiste、Czech Republic、捷克语、686 01
        • Novartis Investigative Site
      • Zlin、Czech Republic、捷克语、760 01
        • Novartis Investigative Site
  • 斯洛伐克
      • Lucenec、斯洛伐克、984 01
        • Novartis Investigative Site
  • 新加坡
      • Singapore、新加坡、119074
        • Novartis Investigative Site
      • Singapore、新加坡、529889
        • Novartis Investigative Site
      • Singapore、新加坡、169608
        • Novartis Investigative Site
  • 比利时
      • Genk、比利时、3600
        • Novartis Investigative Site
      • Gent、比利时、9000
        • Novartis Investigative Site
      • Leuven、比利时、3000
        • Novartis Investigative Site
  • 波兰
      • Bialystok、波兰、15-351
        • Novartis Investigative Site
      • Warszawa、波兰、02-341
        • Novartis Investigative Site
  • 泰国
      • Bangkok、泰国、10400
        • Novartis Investigative Site
      • Chiang Mai、泰国、50200
        • Novartis Investigative Site
    • THA
      • Khon Kaen、THA、泰国、40002
        • Novartis Investigative Site
  • 澳大利亚
    • Queensland
      • Maroochydore、Queensland、澳大利亚、4558
        • Novartis Investigative Site
    • Victoria
      • Malvern East、Victoria、澳大利亚、3145
        • Novartis Investigative Site
  • 美国
    • Alabama
      • Anniston、Alabama、美国、36207-5710
        • Novartis Investigative Site
    • Arizona
      • Mesa、Arizona、美国、85202
        • Novartis Investigative Site
      • Paradise Valley、Arizona、美国、85253
        • Novartis Investigative Site
    • California
      • Upland、California、美国、91786
        • Novartis Investigative Site
    • Florida
      • Tamarac、Florida、美国、33321
        • Novartis Investigative Site
    • Minnesota
      • Eagan、Minnesota、美国、55121
        • Novartis Investigative Site
    • Missouri
      • Saint Louis、Missouri、美国、63117
        • Novartis Investigative Site
    • Nebraska
      • Lincoln、Nebraska、美国、68516
        • Novartis Investigative Site
    • New Jersey
      • Freehold、New Jersey、美国、07728
        • Novartis Investigative Site
    • North Carolina
      • Charlotte、North Carolina、美国、28210
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73103
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville、Pennsylvania、美国、16635
        • Novartis Investigative Site
    • South Carolina
      • Charleston、South Carolina、美国、29460
        • Novartis Investigative Site
      • Columbia、South Carolina、美国、29204
        • Novartis Investigative Site
    • Tennessee
      • Jackson、Tennessee、美国、38305
        • Novartis Investigative Site
    • Texas
      • Benbrook、Texas、美国、76126
        • Novartis Investigative Site
      • Dallas、Texas、美国、75216
        • Novartis Investigative Site
      • Dallas、Texas、美国、75246
        • Novartis Investigative Site
      • Houston、Texas、美国、77074
        • Novartis Investigative Site
      • League City、Texas、美国、77573
        • Novartis Investigative Site
      • Mesquite、Texas、美国、75150
        • Novartis Investigative Site
    • Washington
      • Seattle、Washington、美国、98122
        • Novartis Investigative Site
  • 英国
      • Glasgow、英国、G31 2ER
        • Novartis Investigative Site
      • London、英国、SE1 9RT
        • Novartis Investigative Site
    • London
      • Leytonstone、London、英国、E11 1NR
        • Novartis Investigative Site
    • Staffordshire
      • Cannock、Staffordshire、英国、WS11 2XY
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford、West Yorkshire、英国、BD5 0NA
        • Novartis Investigative Site
  • 菲律宾
      • Las Pinas、菲律宾、1740
        • Novartis Investigative Site
      • Manila、菲律宾、1003
        • Novartis Investigative Site
      • Manila、菲律宾、1008
        • Novartis Investigative Site
      • Quezon City、菲律宾、1102
        • Novartis Investigative Site
      • Quezon City、菲律宾、1118
        • Novartis Investigative Site
    • Batangas
      • Lipa City、Batangas、菲律宾、4217
        • Novartis Investigative Site
    • Cavite
      • Dasmarinas、Cavite、菲律宾、4114
        • Novartis Investigative Site
    • Metro Manila
      • Manila、Metro Manila、菲律宾、1003
        • Novartis Investigative Site
  • 阿根廷
      • Buenos Aires、阿根廷、C1417EYG
        • Novartis Investigative Site
      • Caba、阿根廷、C1419AHN
        • Novartis Investigative Site
      • Cordoba、阿根廷、X5016KEH
        • Novartis Investigative Site
      • Córdoba、阿根廷、X5000EDC
        • Novartis Investigative Site
    • Buenos Aires
      • Caba、Buenos Aires、阿根廷、C1181ACH
        • Novartis Investigative Site
    • Santa Fe
      • Rosario、Santa Fe、阿根廷、S2000CFJ
        • Novartis Investigative Site

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 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria

  • Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
  • Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
  • Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion criteria

  • Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
  • Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)

Other protocol-defined inclusion/exclusion criteria may apply

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：Secukinumab 75mg
Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
药品：Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
其他名称：
  • AIN457
实验性的：Secukinumab 150mg
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
药品：Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
其他名称：
  • AIN457
实验性的：Placebo - AIN457A 75mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg
药品：安慰剂
安慰剂
其他名称：
  • 安慰剂 - AIN457A
药品：Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
其他名称：
  • AIN457
实验性的：Placebo - AIN457 150mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg
药品：安慰剂
安慰剂
其他名称：
  • 安慰剂 - AIN457A
药品：Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
其他名称：
  • AIN457

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
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260

Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

  • Patient's assessment of Psoriatic Arthritis (PsA) pain
  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR50
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260

Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

  • Patient's assessment of PsA pain
  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR70
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260

Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain

  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260

Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.

Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Change From Baseline in Disease Activity Score-CRP (DAS28)
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260

Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores.

DAS28 is a combined measure of disease activity based on the following formula:

DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of Subjects Achieving Low Disease Activity
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
大体时间：weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of subjects achieving disease remission (DAS28<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
weeks 116, 128, 140, 156, 180, 208, 232 and 260

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

Novartis Pharmaceuticals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2013年9月30日

初级完成 (实际的)

2018年1月11日

研究完成 (实际的)

2018年1月11日

研究注册日期

首次提交

2013年7月1日

首先提交符合 QC 标准的

2013年7月1日

首次发布 (估计)

2013年7月4日

研究记录更新

最后更新发布 (实际的)

2019年6月12日

上次提交的符合 QC 标准的更新

2019年5月20日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CAIN457F2306E1
  • 2013-001241-13 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅