NCT00195715已完成3 期
A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 777
- 试验地点
- 220
- 主要终点
- Percentage of Subjects Achieving Clinical Remission
研究概览
简要总结
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study
- •Diagnosis of Crohn's disease
- •Willing and able to give informed consent
排除标准
- •Diagnosis of ulcerative colitis
- •Women cannot be pregnant or breastfeeding
- •Previous history of listeria infection or untreated tuberculosis
- •Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix
结局指标
主要结局
Percentage of Subjects Achieving Clinical Remission
时间窗: Week 156
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
次要结局
- Percentage of Subjects Achieving Clinical Remission(Week 204)
- Percentage of Subjects Achieving Clinical Response 100 (CR-100)(Week 156)
- Percentage of Subjects Achieving Clinical Response 70 (CR-70)(Week 156)
- Percentage of Subjects Achieving Steroid-free Clinical Remission(Week 156)
- Percentage of Subjects Achieving Steroid-free CR-100(Week 156)
- Percentage of Subjects With Fistula Remission(Week 156)
- Percentage of Subjects With Infection(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Serious Infection(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Malignancy(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Lymphoma(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Nonmelanoma Skin Cancer(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Injection Site Reaction-related Adverse Event(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Congestive Heart Failure(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Demyelinating Disease(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Hepatic-related Adverse Event(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Allergic Reaction-related Adverse Event(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Lupus-like Syndrome(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Hematologic-related Adverse Event(Up to 262 weeks of adalimumab treatment)
- Percentage of Subjects With Fatal Adverse Event(Up to 262 weeks of adalimumab treatment)
研究者
研究点 (220)
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