Optimization of Golimumab Treatment in Ulcerative Colitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between serum Golimumab levels and clinical response.
研究概览
简要总结
This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria.
排除标准
- •Patients with Crohn's disease or colitis pending classification
- •Patients with ileoanal pouch
- •Patients with perianal fistulas related to the disease
- •Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet.
- •Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections.
- •Patients with moderate or severe heart failure (NYHA grade III / IV)
研究组 & 干预措施
Week 6 Responders
In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.
干预措施: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg (Drug)
Week 6 Non Responders
In patients without clinical response at week 6, golimumab treatment will be optimized.
干预措施: Golimumab treatment optimization. (Drug)
结局指标
主要结局
Correlation between serum Golimumab levels and clinical response.
时间窗: Week 6.
Serum Golimumab levels will be measured and clinical activity evaluation will be assessed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin.
Correlation between anti-Golimumab antibody levels and clinical response.
时间窗: Week 6.
Anti-golimumab antibody levels will be measure and clinical activity evaluation will be performed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin.
次要结局
- Correlation between mucosal healing and serum Golimumab levels.(Week 54)
- Correlation between mucosal healing and anti-Golimumab antibody levels.(Week 54)
- Treatment optimization outcome.(Week 14)
- Identification of cut-off values of serum golimumab concentration(Week 6)