Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- correlation between concentration of golimumab and clinical response according to treatment
研究概览
简要总结
It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Affiliate or beneficiary of social security
- •Age>18 years
- •Pregnant women or man
- •Presenting primary response under golimumab induction and in loss of response during maintenance therapy
- •Patient with an ulcerative colitis
- •Treated with golimumab
- •Signature of consent
排除标准
- •Trying to become pregnant
- •Mental or emotional disorders
- •Patients with crohn's disease or indeterminate colitis
- •cancer(<5)
- •Patients not in agreement with this study protocol
- •Patients with crohn's disease or indeterminate colitis
- •Patients non primary responder to golimumab
研究组 & 干预措施
Patients treated with golimumab
The optimization procedure is:
- For patients treated at 50 mg of golimumab every 4 weeks (less than 80 kg) will have an increase dose of golimumab: 100 mg every 4 weeks for 8 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
- For patients treated at 100 mg of golimumab every four weeks (more than 80 kg) will have an increase dose of golimumab: treated at 100 mg every 2 weeks for 4 weeks.
They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
干预措施: Golimumab (Optimization) (Drug)
Patients treated with golimumab
The optimization procedure is:
- For patients treated at 50 mg of golimumab every 4 weeks (less than 80 kg) will have an increase dose of golimumab: 100 mg every 4 weeks for 8 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
- For patients treated at 100 mg of golimumab every four weeks (more than 80 kg) will have an increase dose of golimumab: treated at 100 mg every 2 weeks for 4 weeks.
They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
干预措施: Rectosigmoidoscopy (Diagnostic Test)
Patients treated with golimumab
The optimization procedure is:
- For patients treated at 50 mg of golimumab every 4 weeks (less than 80 kg) will have an increase dose of golimumab: 100 mg every 4 weeks for 8 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
- For patients treated at 100 mg of golimumab every four weeks (more than 80 kg) will have an increase dose of golimumab: treated at 100 mg every 2 weeks for 4 weeks.
They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
干预措施: Blood samples (Biological)
结局指标
主要结局
correlation between concentration of golimumab and clinical response according to treatment
时间窗: From baseline to 8 weeks
Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA). Clinical response is measured by the Mayo score.
次要结局
- correlation between concentration of antibodies to golimumab and clinical response according to treatment(From baseline to 8 weeks)
- Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever(up to 8 weeks)
- Number of patient with antibodies to golimumab(day 1)