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Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

2015年3月18日 更新者：Bristol-Myers Squibb

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

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)

56

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

  • 墨西哥
    • Distrito Federal
      • Guadalajara、Distrito Federal、墨西哥
        • Local Institution
    • Guanajuato
      • Leon、Guanajuato、墨西哥
        • Local Institution
    • Jalisco
      • Guadalajara、Jalisco、墨西哥
        • Local Institution
    • Michioacan
      • Morelia、Michioacan、墨西哥
        • Local Institution
  • 德国
      • Berlin、德国
        • Local Institution
      • Dresden、德国
        • Local Institution
      • Hamburg、德国
        • Local Institution
      • Hannover、德国
        • Local Institution
      • Heidelberg、德国
        • Local Institution
  • 意大利
      • Bari、意大利
        • Local Institution
      • Ferrara、意大利
        • Local Institution
      • Milano、意大利
        • Local Institution
  • 比利时
      • Bruxelles、比利时
        • Local Institution
      • Leuven、比利时
        • Local Institution
  • 法国
      • Paris、法国
        • Local Institution
      • Strasbourg Cedex、法国
        • Local Institution
  • 波多黎各
      • Ponce、波多黎各
        • Local Institution
  • 澳大利亚
    • Queensland
      • Cairns、Queensland、澳大利亚
        • Local Institution
    • Victoria
      • Clayton、Victoria、澳大利亚
        • Local Institution
      • Malvern、Victoria、澳大利亚
        • Local Institution
    • Western Australia
      • Shenton Park、Western Australia、澳大利亚
        • Local Institution
  • 美国
    • Alabama
      • Huntsville、Alabama、美国
        • Local Institution
      • Mobile、Alabama、美国
        • Local Institution
    • California
      • Huntington Beach、California、美国
        • Local Institution
      • Los Angeles、California、美国
        • Local Institution
    • Colorado
      • Boulder、Colorado、美国
        • Local Institution
      • Colorado Springs、Colorado、美国
        • Local Institution
    • Florida
      • Ft. Lauderdale、Florida、美国
        • Local Institution
    • Illinois
      • Chicago、Illinois、美国
        • Local Institution
    • Indiana
      • Evansville、Indiana、美国
        • Local Institution
    • Louisiana
      • New Orleans、Louisiana、美国
        • Local Institution
    • Maryland
      • Cumberland、Maryland、美国
        • Local Institution
      • Hagerstown、Maryland、美国
        • Local Institution
    • Minnesota
      • Duluth、Minnesota、美国
        • Local Institution
    • North Carolina
      • Durham、North Carolina、美国
        • Local Institution
      • Wilmington、North Carolina、美国
        • Local Institution
    • Oklahoma
      • Oklahoma City、Oklahoma、美国
        • Local Institution
    • Pennsylvania
      • Willow Grove、Pennsylvania、美国
        • Local Institution
    • South Carolina
      • Charleston、South Carolina、美国
        • Local Institution
    • Texas
      • Austin、Texas、美国
        • Local Institution
    • Virginia
      • Arlington、Virginia、美国
        • Local Institution
  • 英国
    • Merseyside
      • Liverpool、Merseyside、英国
        • Local Institution
    • North Yorkshire
      • Leeds、North Yorkshire、英国
        • Local Institution
  • 西班牙
      • A Coruna、西班牙
        • Local Institution
      • Barcelona、西班牙
        • Local Institution
      • Madrid、西班牙
        • Local Institution
      • Oviedo、西班牙
        • Local Institution
      • Sevilla、西班牙
        • Local Institution

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 75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:

  • Diagnosis of undifferentiated arthritis
  • Clinical synovitis of two or more joints
  • At least one but not more than three of the criteria for diagnosis of RA (1987).
  • No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
  • Duration of disease must be 18 months or less.
  • Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria:

  • Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
  • Active vasculitis of a major organ system.
  • Severe or recurrent bacterial infection.
  • History of cancer in the last five years except certain skin cancers.
  • Herpes zoster that resolved less than 2 months prior to enrollment

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

  • 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
安慰剂比较：2个
药品：placebo
solution, intravenous injection, 0 mg, monthly, 169 days
有源比较器：1个
药品：Abatacept

solution, intravenous injection, monthly, 169 days

weight based:

<60 kg = 500 mg

60 to 100 kg = 750 mg

>100 kg = 1 g

其他名称：
  • 奥伦西亚

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
Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
大体时间：12 months
ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.
12 months

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy
大体时间：24 months
ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
24 months
Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease
大体时间：12 months, 24 months
Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
12 months, 24 months
Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months
大体时间：Baseline, 6 months, 12 months, 24 months
Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.
Baseline, 6 months, 12 months, 24 months
Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months
大体时间：Baseline, 6 months, 12 months, 24 months
Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.
Baseline, 6 months, 12 months, 24 months
Number of Participants With Persistent Symptomatic Clinical Synovitis
大体时间：6, 12, and 24 months
Synovitis, assessed by clinical signs and symptoms
6, 12, and 24 months
Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline
大体时间：6 months, 12 months, 24 months
SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.
6 months, 12 months, 24 months
Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months
大体时间：Baseline, 6 Months, 12 months, 24 months
To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], tumor necrosis factor Alpha [TNF-Alpha], Matrix Metalloproteinase 3T [MMP3T], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.
Baseline, 6 Months, 12 months, 24 months
Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time
大体时间：Day 1, 6 months, 12 months, 24 months
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive
Day 1, 6 months, 12 months, 24 months
Frequency of Human Leukocyte Antigen (HLA) Typing
大体时间：Day 1
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).
Day 1
DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline
大体时间：6 months, 12 months, 24 months
The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.
6 months, 12 months, 24 months
Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)
大体时间：6 months, 12 months, 24 months
The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (< 2.6).
6 months, 12 months, 24 months
Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response
大体时间：6 months, 12 months, 24 months
This questionnaire includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. Higher scores indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.
6 months, 12 months, 24 months
Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths
大体时间：Throughout the treatment period (6 months)
AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely
Throughout the treatment period (6 months)
Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies
大体时间：Up to 12 months
Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of > 400 and for tip assessment was ≥25.
Up to 12 months

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

Bristol-Myers Squibb

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

2005年2月1日

初级完成 (实际的)

2007年5月1日

研究完成 (实际的)

2008年4月1日

研究注册日期

首次提交

2005年6月30日

首先提交符合 QC 标准的

2005年7月27日

首次发布 (估计)

2005年7月28日

研究记录更新

最后更新发布 (估计)

2015年4月7日

上次提交的符合 QC 标准的更新

2015年3月18日

最后验证

2015年3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

  • IM101-046

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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条件

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3
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