A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 88
- 试验地点
- 16
- 主要终点
- Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
研究概览
简要总结
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
- •Completed Week 36 of Study M03-651 [NCT 00235872]
- •Wish to participate in self-injection study
- •Give written informed consent
- •Comply with protocol requirements
排除标准
- •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
结局指标
主要结局
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 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, 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.
次要结局
- Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), 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 Swollen Joint Count (SJC, Max = 66), 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 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(Every 4 weeks 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 (0 - 100 mm With 100 mm Being the Worst Assessment), 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 (0 - 100 mm With 100 mm Being the Worst Pain), 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 Disability Index of the Health Assessment Questionnaire (HAQ), 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 C-reactive Protein (CRP), 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))
- Presence of Morning Stiffness by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value))
- Duration (Minutes) of the Presence of Morning Stiffness by Visit(Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value))