Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
2011年6月17日 更新者：Abbott
A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.
研究概览
研究类型
介入性
注册 (实际的)
88
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
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Aichi、日本
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Chiba、日本
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Fukuoka、日本
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Gunma、日本
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Hokkaido、日本
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Hyogo、日本
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Ibaraki、日本
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Kanagawa、日本
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Miyagi、日本
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Nagano、日本
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Okayama、日本
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Osaka、日本
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Saitama、日本
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Shizuoka、日本
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Tokyo、日本
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Toyama、日本
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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:
- Completed Week 36 of Study M03-651 [NCT 00235872]
- Wish to participate in self-injection study
- Give written informed consent
- Comply with protocol requirements
Exclusion Criteria:
- Subject develops serious adverse events at time of eligibility confirmation
- Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
- Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
- The investigator considers the subject inappropriate for participation
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：非随机化
- 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 |
|---|---|
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实验性的：Adalimumab
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT 00235872]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
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40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
其他名称：
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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 |
|---|---|---|
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Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit.
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
大体时间：Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
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Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
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Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains.
The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities [0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so]), a component of the ACR criteria by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
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Presence of Morning Stiffness by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Duration (Minutes) of the Presence of Morning Stiffness by Visit
大体时间：Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.
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Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
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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。
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
2006年3月1日
初级完成 (实际的)
2006年11月1日
研究注册日期
首次提交
2008年1月10日
首先提交符合 QC 标准的
2008年1月28日
首次发布 (估计)
2008年1月29日
研究记录更新
最后更新发布 (估计)
2011年6月21日
上次提交的符合 QC 标准的更新
2011年6月17日
最后验证
2011年6月1日
更多信息
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.