A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Number of Participants With Marked Improvement at Week 24
研究概览
简要总结
To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intestinal Behçet's disease
- •Patients with typical ulcer at ileocecal region
- •Patients who have failed conventional treatment
排除标准
- •Crohn's disease
- •History of ileocecal resection
- •History of tuberculosis (TB)
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study
研究组 & 干预措施
Adalimumab
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
干预措施: Adalimumab (Biological)
结局指标
主要结局
Number of Participants With Marked Improvement at Week 24
时间窗: 24 weeks
Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to \<2 cm, ≥2 cm to \<3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).
次要结局
- Number of Participants With Marked Improvement at Week 52(52 weeks)
- Number of Participants With Complete Remission at Week 24 and Week 52(24 weeks, 52 weeks)
- Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52(24 weeks, 52 weeks)
- Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52(24 weeks, 52 weeks)
- Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52(24 weeks, 52 weeks)
- Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52(24 weeks, 52 weeks)
- Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52(Baseline, 24 weeks, 52 weeks)
- Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52(Baseline, 24 weeks, 52 weeks)
- Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52(Baseline, 24 weeks, 52 weeks)