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Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

2014年10月22日 更新者：AbbVie (prior sponsor, Abbott)

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

研究概览

地位

完全的

条件

干预/治疗

详细说明

All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.

研究类型

介入性

注册 (实际的)

88

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

  • 德国
      • Ratingen、德国、40882
        • Site Reference ID/Investigator# 92073
  • 捷克共和国
      • Brno、捷克共和国、638 00
        • Site Reference ID/Investigator# 91954
      • Prague 2、捷克共和国、128 50
        • Site Reference ID/Investigator# 91955
      • Uherske Hradiste、捷克共和国、686 01
        • Site Reference ID/Investigator# 91953
      • Zlin、捷克共和国、760 01
        • Site Reference ID/Investigator# 91956
  • 斯洛伐克
      • Banska Bystrica、斯洛伐克、97405
        • Site Reference ID/Investigator# 92096
      • Senica、斯洛伐克、905 01
        • Site Reference ID/Investigator# 92097
      • Zilina、斯洛伐克、010 01
        • Site Reference ID/Investigator# 92098
  • 比利时
      • Brussels、比利时、1200
        • Site Reference ID/Investigator# 92053
      • Liege、比利时、4000
        • Site Reference ID/Investigator# 92054
  • 波多黎各
      • Vega Baja、波多黎各、00693
        • Site Reference ID/Investigator# 92074
  • 罗马尼亚
      • Bucharest、罗马尼亚、020475
        • Site Reference ID/Investigator# 92093
      • Cluj-Napoca、罗马尼亚、400006
        • Site Reference ID/Investigator# 92095
      • Ploiesti、罗马尼亚、100337
        • Site Reference ID/Investigator# 92094
  • 美国
    • Arizona
      • Mesa、Arizona、美国、85202
        • Site Reference ID/Investigator# 92113
    • California
      • Hemet、California、美国、92543
        • Site Reference ID/Investigator# 92118
    • Kansas
      • Wichita、Kansas、美国、67203
        • Site Reference ID/Investigator# 92117
    • New Jersey
      • Clifton、New Jersey、美国、07012
        • Site Reference ID/Investigator# 92115
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19152
        • Site Reference ID/Investigator# 92116
    • South Carolina
      • Charleston、South Carolina、美国、29406
        • Site Reference ID/Investigator# 92114

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:

  1. Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.

  2. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):

    • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
    • Hormonal contraceptives for 90 days prior to study drug administration;
    • A vasectomized partner.
  3. Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
  4. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
  5. Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

  1. Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
  2. Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
  3. Subject plans to use any live vaccine during the study.
  4. Positive pregnancy test at Baseline (Week 0).
  5. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

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：新配方阿达木单抗 40 mg 每隔一周一次
新配方阿达木单抗 40 mg 每隔一周
生物：New formulation adalimumab
New formulation adalimumab 40 mg every other week
其他名称：
  • 修美乐

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
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
大体时间：Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
大体时间：Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

  • ≥ 20% improvement in tender joint count;
  • ≥ 20% improvement in swollen joint count; and

  • ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
大体时间：Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:

  • ≥ 50% improvement in tender joint count;
  • ≥ 50% improvement in swollen joint count; and

  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment
    • CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
大体时间：Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.
Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Positive for Anti-adalimumab Antibody
大体时间：Week 24 through Week 48
Percentage of participants with anti-adalimumab antibody
Week 24 through Week 48

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

AbbVie (prior sponsor, Abbott)

调查人员

  • 研究主任：Andy Payne, PhD、AbbVie

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。

有用的网址

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

2012年12月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2012年12月17日

首先提交符合 QC 标准的

2012年12月18日

首次发布 (估计)

2012年12月19日

研究记录更新

最后更新发布 (估计)

2014年10月29日

上次提交的符合 QC 标准的更新

2014年10月22日

最后验证

2014年10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

  • M13-692
  • 2012-003881-42 (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.

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