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。

A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis

2015年10月23日 更新者：Vertex Pharmaceuticals Incorporated

A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).

研究概览

地位

完全的

条件

干预/治疗

详细说明

VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA.

This study will follow a "treat to target" (T2T) paradigm. T2T strategies have been followed in non-rheumatologic fields for decades. T2T trials have been conducted for RA from the late 1990's, and have substantiated the concept that treating to a target is associated with a better outcome than standard of care treatment. This has led to recommendations by experts to use T2T strategies in clinical practice.

研究类型

介入性

注册 (实际的)

39

阶段

  • 阶段2
  • 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

  • 南非
      • Pretoria、南非
        • Vertex Investigational Site
      • Stellenbosch、南非
        • Vertex Investigational Site
  • 爱沙尼亚
      • Tallinn、爱沙尼亚
        • Vertex Investigational Site
  • 立陶宛
      • Vilnius、立陶宛
        • Vertex Investigational Site
  • 美国
    • California
      • Upland、California、美国
        • Vertex Investigational Site
    • Florida
      • Fort Lauderdale、Florida、美国
        • Vertex Investigational Site
      • Venice、Florida、美国
        • Vertex Investigational Site
      • West Palm Beach、Florida、美国
        • Vertex Investigational Site
    • Georgia
      • Canton、Georgia、美国
        • Vertex Investigational Site
      • Decatur、Georgia、美国
        • Vertex Investigational Site
    • Kentucky
      • Elizabethtown、Kentucky、美国
        • Vertex Investigational Site
    • Maryland
      • Fredrick、Maryland、美国
        • Vertex Investigational Site
    • Nebraska
      • Lincoln、Nebraska、美国
        • Vertex Investigational Site
    • New York
      • Rochester、New York、美国
        • Vertex Investigational Site
    • North Carolina
      • Greensboro、North Carolina、美国
        • Vertex Investigational Site
    • Pennsylvania
      • Duncansville、Pennsylvania、美国
        • Vertex Investigational Site
    • South Carolina
      • Charleston、South Carolina、美国
        • Vertex Investigational Site
    • Tennessee
      • Memphis、Tennessee、美国
        • Vertex Investigational Site
    • Texas
      • Katy、Texas、美国
        • Vertex Investigational Site
      • San Antonio、Texas、美国
        • Vertex Investigational Site
      • Webster、Texas、美国
        • Vertex Investigational Site
    • Washington
      • Spokane、Washington、美国
        • Vertex Investigational 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 至 65年 (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 have completed the assigned study drug treatment phase of a previous VX-509 study (e.g., Study 103).
  • Subjects must voluntarily sign and date the Study 104 informed consent document.
  • Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria:

  • Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature.
  • History of any clinically significant illness that might, in the opinion of the investigator, confound the results of the study or pose an additional risk in administering study drug(s) to the subject
  • History of tuberculosis (TB), regardless of history of antimycobacterial treatment.
  • Planned surgery during the study.
  • History of alcohol or drug abuse, or excessive alcohol consumption as determined by the investigator, during the previous 12 months before Day 1.
  • Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Single Arm VX-509
药品：VX-509
VX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI)

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
Long-term safety and tolerability of VX-509 treatment
大体时间：Baseline through 104 weeks
Measured by clinical laboratory tests
Baseline through 104 weeks
Long-term safety and tolerability of VX-509 treatment
大体时间：Baseline through 104 weeks
Measured by adverse events (AEs)
Baseline through 104 weeks
Long-term safety and tolerability of VX-509 treatment
大体时间：Baseline through 104 weeks
Measured by electrocardiograms (ECGs)
Baseline through 104 weeks
Long-term safety and tolerability of VX-509 treatment
大体时间：Baseline through 104 weeks
Measured by vital signs
Baseline through 104 weeks

次要结果测量

结果测量
大体时间
Proportion of subjects who achieve CDAI LDA (≤10) or CDAI remission (≤2.8)
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects who achieve ≥20% (50%, 70%) improvement in disease severity according to the ACR criteria, using CRP (ACR20 CRP, ACR50 CRP, ACR70 CRP)
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Change from baseline in DAS28 using CRP (4-component) (DAS28 4[CRP])
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects with DAS28 4(CRP) <2.6 (DAS remission)
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects who achieve a moderate, good, or no response according to the EULAR response criteria from baseline
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Percentage of subjects with decreased dose of DMARD and/or corticosteroid (if receiving), including the subsets with 50% withdrawal and with full withdrawal (dose = 0)
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
ACR hybrid scores
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects who achieve ACR20/50/70 with erythrocyte sedimentation rate (ESR) and DAS28 4(ESR) response from baseline
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects with DAS28 4(CRP) <3.2 (DAS LDA) from baseline
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects achieving a clinical remission (2011 ACR/EULAR criteria), including subsets achieving either the low joint count or simplified disease activity index (SDAI) score remission options (or both) from baseline
大体时间：Baseline through week 104
Baseline through week 104
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
大体时间：Baseline through 104 weeks
Baseline through 104 weeks
Change from baseline in health-related quality of life assessed by 36-Item Short Form (SF 36) Physical Component Summary score and Physical Function (PF) subscale
大体时间：Baseline through 104 weeks
Baseline through 104 weeks

其他结果措施

结果测量
大体时间
Change in Outcome Measures in Rheumatology Clinical Trials (OMERACT) RAMRIS synovitis score, bone marrow edema (osteitis), erosion score, and joint space narrowing score by magnetic resonance imaging (MRI) in the designated hand
大体时间：Baseline through week 12
Baseline through week 12

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

Vertex Pharmaceuticals Incorporated

调查人员

  • 学习椅：Bradley Bloom, MD, FACR, FAAP、Vertex Pharmaceuticals Incorporated

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

2013年4月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2013年4月10日

首先提交符合 QC 标准的

2013年4月10日

首次发布 (估计)

2013年4月12日

研究记录更新

最后更新发布 (估计)

2015年11月20日

上次提交的符合 QC 标准的更新

2015年10月23日

最后验证

2015年10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

  • VX12-509-104
  • 2012-004342-14 (EudraCT编号)

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