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Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)

2014年6月6日 更新者：Biogen

Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients (BATTER-UP)

The primary objective of this study was to validate the ability of an 8-gene biomarker set to differentiate between participants who met or did not meet European League Against Rheumatism (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment with anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200 anti-TNF-naïve participants. The secondary objectives of this study was (i) to compare the behavior of the 8-gene marker set in participants who were anti-TNF naïve versus those who began their second anti-TNF treatment , (ii) to develop, maintain, and utilize a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses and (iii) to discover novel genetic (DNA) predictors of response to anti-TNF therapy.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

301

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

  • 美国
    • California
      • Murietta、California、美国
        • Research Site
    • Colorado
      • Longmont、Colorado、美国
        • Research Site
    • Delaware
      • Lewes、Delaware、美国
        • Research Site
    • Florida
      • Dunedin、Florida、美国
        • Research Site
      • Ocala、Florida、美国
        • Research Site
      • Orange Park、Florida、美国
        • Research Site
    • Illinois
      • Morton Grove、Illinois、美国
        • Research Site
    • Maryland
      • Baltimore、Maryland、美国
        • Research Site
    • Massachusetts
      • Plymouth、Massachusetts、美国
        • Research Site
    • Nevada
      • Las Vegas、Nevada、美国
        • Research Site
      • Reno、Nevada、美国
        • Research Site
    • New Jersey
      • Berkeley Heights、New Jersey、美国
        • Research Site
      • Summit、New Jersey、美国
        • Research Site
    • New York
      • Floral Park、New York、美国
        • Research Site
      • Orchard Park、New York、美国
        • Research Site
      • Smithtown、New York、美国
        • Research Site
    • North Carolina
      • Raleigh、North Carolina、美国
        • Research Site
      • Wilmington、North Carolina、美国
        • Research Site
    • Ohio
      • Cincinnati、Ohio、美国
        • Research Site
      • Mayfield Village、Ohio、美国
        • Research Site
      • Middleburg Heights、Ohio、美国
        • Research Site
    • Oklahoma
      • Edmund、Oklahoma、美国
        • Research Site
    • Pennsylvania
      • Duncansville、Pennsylvania、美国
        • Research Site
    • South Carolina
      • Mrytle Beach、South Carolina、美国
        • Research Site
    • Texas
      • Dallas、Texas、美国
        • Research Site
      • San Anotnio、Texas、美国
        • Research Site
    • Virginia
      • Burke、Virginia、美国
        • Research Site
    • Washington
      • Seattle、Washington、美国
        • Research Site
      • Spokane、Washington、美国
        • Research Site
    • Wisconsin
      • Franklin、Wisconsin、美国
        • Research 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

取样方法

非概率样本

研究人群

Participants who meet American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA) and who, in the opinion of their treating rheumatologist, are not adequately treated with existing therapy and should begin treatment with either an anti TNF agent for the first time or with a different anti-TNF agent.

描述

Key Inclusion Criteria

To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of enrollment:

  • Are willing and able to provide informed consent..
  • Meet the ACR criteria for RA as determined by a rheumatologist who is board certified in Rheumatology or a member of the ACR.
  • Have 4 or more tender and 4 or more swollen joints out of 28 joints as assessed by their treating rheumatologist or a trained joint assessor.

  • Subjects are not taking any of the following treatments and/or have washed out for the minimum duration as defined below. If subjects are currently taking these treatments, must have been on a stable dosing regimen for the minimum duration as defined below:

    • Oral DMARDs (MTX, hydroxychloroquine, sulfasalazine, leflunomide, cyclosporine, azathioprine): on drug for at least 3 months and washed out or stable for at least 6 weeks prior to baseline sample collection.
    • Oral corticosteroids: washed out or stable AND ≤10 mg/day of prednisone equivalent for at least 4 weeks prior to baseline sample collection.
    • Intraarticular or parenteral corticosteroids: Washed out or stable for at least 4 weeks prior to baseline sample collection.
    • NSAIDs: Washed out or stable for at least 2 weeks prior to baseline sample collection.
  • Are about to start treatment with an anti-TNF agent approved for the treatment of RA for the first time OR Have not, in the opinion of the treating rheumatologist, achieved or maintained an adequate response to treatment with their first anti-TNF agent (any anti-TNF agent approved for the treatment of RA), and have been prescribed a different anti TNF agent. Subjects who switch for any reason other than lack of efficacy will be excluded.

Key Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:

  • Any medical condition that would preclude safe use of an anti-TNF agent for at least 14 weeks.
  • Previous participation in the present study as a subject in the anti-TNF-naïve group.
  • Prior exposure to 2 or more anti-TNF agents.
  • Prior exposure to Orencia (abatacept, or CTLA4-Ig) and/or Rituxan (anti CD20), or other biologic therapy for RA or other diseases.

Note: 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

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Validation of the ability of an 8-gene biomarker set to differentiate between participants who meet or do not meet EULAR DAS-28 Good response criteria after treatment with anti-TNF therapy
大体时间：14 weeks
14 weeks

次要结果测量

结果测量
大体时间
Comparison of the behavior of the 8-gene marker set in participants who are anti-TNF naïve versus those who begin their second anti-TNF treatment
大体时间：14 weeks
14 weeks
Development, maintenance, and utilization of a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses.
大体时间：14 weeks
14 weeks
Discovery of novel genetic (DNA) predictors of response to anti-TNF therapy.
大体时间：14 weeks
14 weeks

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

Biogen

合作者

Crescendo Biosciences

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

2010年6月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2010年9月28日

首先提交符合 QC 标准的

2010年9月28日

首次发布 (估计)

2010年9月29日

研究记录更新

最后更新发布 (估计)

2014年6月9日

上次提交的符合 QC 标准的更新

2014年6月6日

最后验证

2014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

  • 999RA002

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.

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