NCT00235872已完成3 期
Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 309
- 试验地点
- 25
- 主要终点
- Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
研究概览
简要总结
The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
- •Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
- •Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.
排除标准
- •A subject who experienced any of the following during prior study:
- •Advanced or poorly controlled diabetes
- •Joint surgery (joint evaluated in this study)
- •A subject who has been prescribed excluded medications during prior study.
- •History of following during prior study:
- •Clinically significant drug or alcohol abuse
- •Intravenous (iv) drug abuse
- •Active infection with listeria or tuberculosis (TB)
- •Lymphoma, leukemia
- •And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
- •A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
结局指标
主要结局
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
时间窗: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, 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 functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
次要结局
- Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
- Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
- Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).)
- Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).)
- Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).)
- Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
- Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
- Presence of Morning Stiffness(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
- Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
- Presence of Rheumatoid Factor (RF)(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
- Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value))
研究者
研究点 (25)
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