A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.
详细描述
Subjects who are confirmed to meet all of the inclusion criteria and none of the exclusion criteria during screening period (≤ 21 days) will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50. If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study. Self-injection of study drug is permitted for the subjects who are willing to perform self-injection, if the investigator decided as appropriate. Disease activity will be evaluated by Crohn's disease activity index (CDAI) at Screening, Week 0 and every 4 weeks until Week 52. Follow-up will be performed at 70 days after the last dose of study drug by visit or telephone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subject ≥ 15 years of age at the time of informed consent.
- •Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®.
- •Subject with elevated C-reactive Protein (CRP) at Screening.
- •If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug.
- •Subject has a negative tuberculosis (TB) screening assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.
排除标准
- •Subject with suspicion of colitis other than Crohn's disease.
- •Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
- •Subject with abscess or suspicion of abscess, or subject with infection(s).
结局指标
主要结局
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
时间窗: Week 8
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
次要结局
- Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Heart Rate: Mean Change From Baseline (Week 0) to Each Visit(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Body Temperature: Mean Change From Baseline (Week 0) to Each Visit(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52(Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52(Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Number of Participants With Potentially Significant Hematology Parameters(52 weeks)
- Number of Participants With Potentially Significant Clinical Chemistry Parameters(52 weeks)
- Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit(Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52)
- Number of Participants With Adverse Events (AEs)(60 weeks)