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Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy (PRINT)

2013年1月31日 更新者：TcLand Expression S.A.

Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy

Study Design & Objectives:

Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.

To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.

Ancillary study objective:

To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.

研究概览

地位

终止

条件

详细说明

The RA-INF-Dx test is a non invasive in vitro blood test intended to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.

The RA-INF-Dx test is indicated for use in patients:

  • 18 years of age or older,
  • Eligible for a first line biologic therapy with infliximab. The RA-INF-Dx test is indicated for use by rheumatologists as a biological basis for guiding infliximab treatment prior to its initiation.

研究类型

观察性的

注册 (实际的)

123

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

  • 加拿大
      • Mississauga - Chow、加拿大
        • Location n°31
      • Ontario、加拿大
        • Location n°36
      • Rimouski、加拿大
        • Location n°34
      • Saskatchewan、加拿大
        • Location n°33
      • Toronto、加拿大
        • Location n°35
  • 匈牙利
      • Budapest、匈牙利
        • Location n°6
      • Budapest、匈牙利
        • Location n°8
      • Debrecen、匈牙利
        • Location n°7
      • Eger、匈牙利
        • Location n°10
      • Kistarcsa、匈牙利
        • Location n°9
  • 意大利
      • Messina、意大利
        • Location n°15
      • Milano、意大利
        • Location n°16
      • Pisa、意大利
        • Location n°17
  • 斯洛伐克
      • Banska Bystrica、斯洛伐克
        • Location n°12
      • Piestany、斯洛伐克
        • Location n°11
  • 法国
      • Amiens、法国
        • Location n°41
      • Bobigny、法国
        • Location n°13
      • Dreux、法国
        • Location n°39
      • Grenoble、法国
        • Location n°14
      • Meaux、法国
        • Location n°40
      • Paris、法国
        • Location n°25
      • Paris (Hop Bichat)、法国
        • Location n°37
      • Strasbourg、法国
        • Location n°38
  • 立陶宛
      • Kaunas、立陶宛
        • Location n°27
      • Klaipeda、立陶宛
        • Location n°29
      • Panevezys、立陶宛
        • Location n°30
      • Vilnius、立陶宛
        • Location n°28
  • 罗马尼亚
      • Bucharest、罗马尼亚
        • Location n° 19
      • Bucharest、罗马尼亚
        • Location n°20
      • Bucharest、罗马尼亚
        • Location n°22
      • Bucharest、罗马尼亚
        • Location n°23
      • Cluj Napoca、罗马尼亚
        • Location n°21
      • Iasi、罗马尼亚
        • Location n°24
      • Iasi、罗马尼亚
        • Location n°26
      • Timisoara、罗马尼亚
        • Location n°18
  • 西班牙
      • Malaga、西班牙
        • Location n°3
      • Oviedo、西班牙
        • Location n°5

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

Patients suffering from RA eligible to a first biologic therapy for whom the treating rheumatologist envisages infliximab therapy will be included in this study.

描述

Inclusion Criteria:

Diagnosis of Rheumatoid Arthritis

  1. Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.

    Disease Activity

  2. Patient with a DAS28 greater than 3.2.

    Treatment

  3. Patient eligible for a first line TNFα blocking agent treatment with infliximab according to the "Summary of Product Characteristics",
  4. Patient refractory to treatment with at least one classical DMARDs (one of which has to be MTX) prescribed according to the international recommendations, i.e. for at least 12 weeks at the maximal tolerated dose prior to infliximab treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy (patients may be included if they have undergone a wash-out period using cholestyramine or equivalent subsequent to leflunomide treatment),

  5. Use of oral steroids (≤ 10mg/day of prednisone or equivalent dose of another molecule) and/or NSAIDs will be permitted; doses must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy,

    Other criteria

  6. Patient (male or female) at 18 years of age or older at inclusion,
  7. Negative β-HCG pregnancy test, when appropriate according to the patient's age and contraceptive method,
  8. Informed consent signed.

Exclusion Criteria:

  1. Patient having received previous courses of other biologic therapy (TNF blocking agents, anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development),
  2. Patient non eligible to infliximab therapy according to the "Summary of Product Characteristics",
  3. Patient with clinically significant, severe and uncontrolled infectious diseases,
  4. Patient with symptoms of a significant somatic or psychiatric/mental illness,
  5. Patient with other auto-immune diseases (i.e. Inflammatory Bowel Diseases, Systemic Lupus Erythematosus, vasculitis, uncontrolled asthma, etc...),
  6. Patient with evidence of cardiac, pulmonary, metabolic, renal, hepatic, gastro-intestinal conditions, which, in the opinion of the investigator, may interfere with the study,
  7. Pregnancy,
  8. Patient that is participating in a clinical trial or that participated in a previous one within 10 weeks prior to study entry.

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

队列和干预

团体/队列
a single group of patients -200 expected
polyarthrite rhumatoid patients

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
To determine the performances of the RA-INF-Dx test to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.
大体时间：Performed at inclusion : blood samples will be taken before the infliximab infusion.
Statistical relationship between the RA-INF-Dx blood test results and the non-response (evaluated according to EULAR criteria) to infliximab and methotrexate combination therapy will be analyzed.
Performed at inclusion : blood samples will be taken before the infliximab infusion.

次要结果测量

结果测量
措施说明
大体时间
Non-response to infliximab and methotrexate combination therapy based on American College of Rheumatology (ACR) criteria
大体时间：at the time of the first response evaluation (between the 12th and the 14th week)
A statistical analysis will be performed in order to evaluate the predictive performances of the test validated in the study primary objective in relation to the non-response to infliximab and methotrexate combination therapy evaluated according to ACR criteria.
at the time of the first response evaluation (between the 12th and the 14th week)

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

TcLand Expression S.A.

合作者

Premier Research Group plc
Theradis pharma
Medpharmgene, Inc.

调查人员

  • 首席研究员：Sara MARSAL, MD、University Hospital Val d'Hebron (Barcelona, Spain)

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

2011年2月1日

初级完成 (实际的)

2012年10月1日

研究完成 (实际的)

2012年10月1日

研究注册日期

首次提交

2011年2月16日

首先提交符合 QC 标准的

2011年2月16日

首次发布 (估计)

2011年2月18日

研究记录更新

最后更新发布 (估计)

2013年2月1日

上次提交的符合 QC 标准的更新

2013年1月31日

最后验证

2013年1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

  • 2010-A01046-33

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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