Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of patients in clinical remission
研究概览
简要总结
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.
详细描述
Adalimumab (ADM), a fully human tumor necrosis factor (TNF) antagonist, is effective for treating patients with Crohn's disease (CD). A correlation between concentration and effect was observed at distinct time points.
The aim was to evaluate the correlation of early longitudinal measurements of ADM with different biological markers for disease activity and induction and maintenance of clinical remission.
This is a prospective two-center open-label observational study in anti-TNF naïve patients with moderate to severe CD induced with ADM 160/80 mg at week 0 and 2 and 40 mg every 2 weeks in monotherapy. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium). Serum samples were taken pre and post first injection and at weeks 1, 2, 3, 4, 12, 26 and 52. Following parameters were determined: C-reactive protein, albumin, TNF, ADM, antibodies to ADM, hemoglobin, platelet count and leukocyte count. Clinical response and remission was evaluated using the Harvey-Bradshaw index.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of Crohn's disease, fulfilling the criteria for reimbursement (Belgium).
- •Patients with active disease defined as a Harvey-Bradshaw index >4 and/or a C-reactive protein concentration >5 mg/l.
- •Informed consent.
排除标准
- •Patients with ulcerative colitis.
- •Patients treated in placebo controlled trials.
- •Patients unwilling to participate or withdrawing informed consent for this study.
研究组 & 干预措施
Single-group study
Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Proportion of patients in clinical remission
时间窗: week 12
As defined by a Harvey-Bradshaw index ≤4
次要结局
未报告次要终点