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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

2012年8月1日 更新者：Abbott

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug [adalimumab or placebo] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

研究类型

介入性

注册 (实际的)

334

阶段

  • 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

  • 日本
      • Anjo、日本
        • Site Reference ID/Investigator# 46861
      • Aomori、日本
        • Site Reference ID/Investigator# 46919
      • Chiba、日本
        • Site Reference ID/Investigator# 46805
      • Chiba、日本
        • Site Reference ID/Investigator# 46806
      • Chiba、日本
        • Site Reference ID/Investigator# 46880
      • Chiba、日本
        • Site Reference ID/Investigator# 46881
      • Fuchu、日本
        • Site Reference ID/Investigator# 46890
      • Fukuoka、日本
        • Site Reference ID/Investigator# 46902
      • Fukuoka、日本
        • Site Reference ID/Investigator# 46903
      • Fukuoka、日本
        • Site Reference ID/Investigator# 46904
      • Gifu、日本
        • Site Reference ID/Investigator# 46856
      • Gunma、日本
        • Site Reference ID/Investigator# 46944
      • Hiroshima、日本
        • Site Reference ID/Investigator# 46893
      • Hiroshima、日本
        • Site Reference ID/Investigator# 46894
      • Hokkaido、日本
        • Site Reference ID/Investigator# 12161
      • Hokkaido、日本
        • Site Reference ID/Investigator# 46916
      • Hokkaido、日本
        • Site Reference ID/Investigator# 46918
      • Hyogo、日本
        • Site Reference ID/Investigator# 46865
      • Hyogo、日本
        • Site Reference ID/Investigator# 46871
      • Ibaraki、日本
        • Site Reference ID/Investigator# 46801
      • Ibaraki、日本
        • Site Reference ID/Investigator# 46925
      • Iwate、日本
        • Site Reference ID/Investigator# 46800
      • Kagoshima、日本
        • Site Reference ID/Investigator# 46873
      • Kagoshima、日本
        • Site Reference ID/Investigator# 46874
      • Kanagawa、日本
        • Site Reference ID/Investigator# 46845
      • Kanagawa、日本
        • Site Reference ID/Investigator# 46899
      • Kanagawa、日本
        • Site Reference ID/Investigator# 46901
      • Kanazawa、日本
        • Site Reference ID/Investigator# 46851
      • Kanazawa、日本
        • Site Reference ID/Investigator# 46852
      • Kawagoe、日本
        • Site Reference ID/Investigator# 46802
      • Kawasaki、日本
        • Site Reference ID/Investigator# 46900
      • Kirishima、日本
        • Site Reference ID/Investigator# 46875
      • Kitakyushu、日本
        • Site Reference ID/Investigator# 46870
      • Kumamoto、日本
        • Site Reference ID/Investigator# 46872
      • Kumamoto、日本
        • Site Reference ID/Investigator# 46912
      • Kyoto、日本
        • Site Reference ID/Investigator# 46864
      • Maebashi、日本
        • Site Reference ID/Investigator# 46943
      • Matsuyama、日本
        • Site Reference ID/Investigator# 46898
      • Miyazaki、日本
        • Site Reference ID/Investigator# 46915
      • Nagano、日本
        • Site Reference ID/Investigator# 46853
      • Nagano、日本
        • Site Reference ID/Investigator# 46855
      • Nagasaki、日本
        • Site Reference ID/Investigator# 46909
      • Nagasaki、日本
        • Site Reference ID/Investigator# 46910
      • Nagasaki、日本
        • Site Reference ID/Investigator# 46911
      • Nagoya、日本
        • Site Reference ID/Investigator# 46858
      • Nagoya、日本
        • Site Reference ID/Investigator# 46860
      • Nara、日本
        • Site Reference ID/Investigator# 46877
      • Nara、日本
        • Site Reference ID/Investigator# 46885
      • Niigata、日本
        • Site Reference ID/Investigator# 46848
      • Niigata、日本
        • Site Reference ID/Investigator# 46906
      • Oita、日本
        • Site Reference ID/Investigator# 46914
      • Okayama、日本
        • Site Reference ID/Investigator# 46869
      • Okayama、日本
        • Site Reference ID/Investigator# 46886
      • Okayama、日本
        • Site Reference ID/Investigator# 46887
      • Okayama、日本
        • Site Reference ID/Investigator# 46892
      • Okinawa、日本
        • Site Reference ID/Investigator# 46876
      • Osaka、日本
        • Site Reference ID/Investigator# 46946
      • Osaka、日本
        • Site Reference ID/Investigator# 46947
      • Rifu、日本
        • Site Reference ID/Investigator# 46842
      • Sagamihara、日本
        • Site Reference ID/Investigator# 46846
      • Saitama、日本
        • Site Reference ID/Investigator# 46803
      • Saitama、日本
        • Site Reference ID/Investigator# 46804
      • Saitama、日本
        • Site Reference ID/Investigator# 46878
      • Saitama、日本
        • Site Reference ID/Investigator# 46879
      • Sapporo、日本
        • Site Reference ID/Investigator# 46917
      • Shimotsuke、日本
        • Site Reference ID/Investigator# 46942
      • Shizuoka、日本
        • Site Reference ID/Investigator# 46854
      • Shizuoka、日本
        • Site Reference ID/Investigator# 46857
      • Shizuoka、日本
        • Site Reference ID/Investigator# 46859
      • Takamatsu、日本
        • Site Reference ID/Investigator# 46895
      • Tokyo、日本
        • Site Reference ID/Investigator# 46843
      • Tokyo、日本
        • Site Reference ID/Investigator# 46844
      • Tokyo、日本
        • Site Reference ID/Investigator# 46850
      • Tokyo、日本
        • Site Reference ID/Investigator# 46882
      • Tokyo、日本
        • Site Reference ID/Investigator# 46883
      • Tokyo、日本
        • Site Reference ID/Investigator# 46884
      • Tokyo、日本
        • Site Reference ID/Investigator# 46888
      • Tokyo、日本
        • Site Reference ID/Investigator# 46889
      • Tokyo、日本
        • Site Reference ID/Investigator# 46891
      • Tokyo、日本
        • Site Reference ID/Investigator# 46896
      • Toyama、日本
        • Site Reference ID/Investigator# 46849
      • Toyama、日本
        • Site Reference ID/Investigator# 46907
      • Toyoake、日本
        • Site Reference ID/Investigator# 46862
      • Toyohashi、日本
        • Site Reference ID/Investigator# 46866
      • Tsu、日本
        • Site Reference ID/Investigator# 46863
      • Tsukuba、日本
        • Site Reference ID/Investigator# 46926
      • Yokohama、日本
        • Site Reference ID/Investigator# 46897
      • Yokohama、日本
        • Site Reference ID/Investigator# 46905

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

20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

  • Rheumatoid arthritis based on the American College of Rheumatology criteria
  • Methotrexate or leflunomide naïve
  • Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

  • History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
  • Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
  • Joint surgery involving joints to be assessed within 8 weeks prior to Screening

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：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：DB Placebo
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
药品：Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
其他名称：
  • 安慰剂
实验性的：DB adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
生物：Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
其他名称：
  • ABT-D2E7、阿达木单抗、修美乐
实验性的：DB Adalimumab/OL Adalimumab
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
生物：Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
其他名称：
  • ABT-D2E7、阿达木单抗、修美乐
生物：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
其他名称：
  • 阿达木单抗
  • ABT-D2E7
  • 修美乐
实验性的：DB Placebo/OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
药品：Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
其他名称：
  • 安慰剂
生物：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
其他名称：
  • 阿达木单抗
  • ABT-D2E7
  • 修美乐
实验性的：DB Adalimumab/RE OL Adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
生物：Double-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
其他名称：
  • ABT-D2E7、阿达木单抗、修美乐
生物：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
其他名称：
  • 阿达木单抗
  • ABT-D2E7
  • 修美乐
生物：Open-labelAdalimumabRescue
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
其他名称：
  • 阿达木单抗
  • ABT-D2E7
  • 修美乐
实验性的：DB Placebo/RE OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
药品：Double-blind Placebo
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
其他名称：
  • 安慰剂
生物：Open-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
其他名称：
  • 阿达木单抗
  • ABT-D2E7
  • 修美乐
生物：Open-labelAdalimumabRescue
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
其他名称：
  • 阿达木单抗
  • ABT-D2E7
  • 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
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
大体时间：Baseline, Week 26
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 26

次要结果测量

结果测量
措施说明
大体时间
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
大体时间：Week 26
Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
大体时间：Week 26
Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
大体时间：Week 26
Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
大体时间：Baseline, Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 26
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
大体时间：Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 26
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
大体时间：Through Week 26
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.
Through Week 26
Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
大体时间：Baseline, Week 52
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 52
Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
大体时间：Week 52
Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
大体时间：Week 52
Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
大体时间：Week 52
Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
大体时间：Baseline, Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 52
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
大体时间：Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 52
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
大体时间：Through Week 52
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.
Through Week 52

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

Abbott

合作者

Eisai Co., Ltd.

调查人员

  • 研究主任：Hiroshi Ukai, BS、Abbott Japan Co.,Ltd

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

2009年3月1日

初级完成 (实际的)

2011年3月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2009年3月26日

首先提交符合 QC 标准的

2009年3月26日

首次发布 (估计)

2009年3月27日

研究记录更新

最后更新发布 (估计)

2012年8月7日

上次提交的符合 QC 标准的更新

2012年8月1日

最后验证

2012年8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

  • M06-859

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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