A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Mean Serum Adalimumab Concentration at Week 8
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of Chinese descent with full Chinese parentage.
- •Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0 confirmed by endoscopy, radiologic evaluation, and/or histology during the Screening Period.
- •Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450 despite treatment with oral corticosteroids and/or immunosuppressants.
- •Subject has a negative Tuberculosis (TB) Screening Assessment.
排除标准
- •Subject with ulcerative colitis or indeterminate colitis.
- •Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.
- •Subject with an ostomy or ileoanal pouch.
- •Subject who has short bowel syndrome.
- •Subject with symptomatic known obstructive strictures.
- •Subject with an internal or external fistula (with the exception of an anal fistula without abscess).
- •Chronic recurring infections or active TB.
研究组 & 干预措施
Low Induction Dose
Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
干预措施: Placebo for adalimumab (Biological)
Standard Induction Dose
Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
干预措施: Adalimumab (Biological)
Low Induction Dose
Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
干预措施: Adalimumab (Biological)
结局指标
主要结局
Mean Serum Adalimumab Concentration at Week 8
时间窗: Week 8
Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.
次要结局
- Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab(26 weeks)
- Number of Participants With Adverse Events (AEs)(35 weeks)
- Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab(From Week 0 to Week 26)
- High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26(Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26)
- CDAI: Mean Change From Baseline to Each Visit(Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26)
- Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab(26 weeks)
- Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26(Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26)
- Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26(Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26)
- Fecal Calprotectin: Change From Baseline (Week 0) to Week 8(Baseline (Week 0) and Weeks 4 and 8)