Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (GO-LEVEL)
The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).
Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.
研究概览
详细说明
The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy:
Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study.
Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study.
Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14.
Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14.
Exploratory objectives:
Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control).
Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity.
This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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London、英国
- Guy's & St Thomas' NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria for cohort 1:
- Aged 18 years or over
- Moderate-to-severe UC, defined as:
SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment
- Commencing golimumab treatment
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Inclusion Criteria for cohort 2:
- Aged 18 years or over
- Receiving golimumab treatment for UC for over 18 weeks (6 injections)
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Exclusion Criteria (cohort 1 only):
- Contra-indication to golimumab: tuberculosis or severe infections
- Imminent need for colectomy (i.e. colectomy is being planned)
- Previous primary non-response to anti-TNF therapy in the opinion of the investigator
- Previous treatment with more than one anti-TNF therapy (excluding golimumab)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Induction cohort
Golimumab induction therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
其他名称：
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其他：Maintenance cohort
Golimumab maintenance therapy
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A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum Golimumab Concentration (μg/ml)
大体时间：Week 6 during induction therapy and at the point of study entry during maintenance
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Evaluated using an enzyme-linked immunosorbent assay (ELISA)
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Week 6 during induction therapy and at the point of study entry during maintenance
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Patients in Clinical Remission
大体时间：Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Evaluated using the Simple Clinical Colitis Activity Index (SCCAI).
Remission defined as SCCAI < 3.
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Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Faecal Calprotectin (μg/g)
大体时间：Week 14 during induction therapy and at the point of study entry during maintenance
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Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity
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Week 14 during induction therapy and at the point of study entry during maintenance
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Serum C-Reactive Protein (mg/L)
大体时间：Week 14 during induction therapy and at the point of study entry during maintenance
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Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity
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Week 14 during induction therapy and at the point of study entry during maintenance
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Serum Albumin (g/L)
大体时间：Week 14 during induction therapy and at the point of study entry during maintenance
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Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)
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Week 14 during induction therapy and at the point of study entry during maintenance
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Clinical UC Disease Activity
大体时间：Week 14 during maintenance therapy and at the point of study entry during maintenance
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Evaluated using Patient Reported Outcome 2 (PRO2).
PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity.
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Week 14 during maintenance therapy and at the point of study entry during maintenance
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Quality of Life (IBD-Control)
大体时间：Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Evaluated using IBD-Control questionnaires.
IBD-Control scores range from 0-16 with higher scores denoting better quality of life.
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Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Number of Patients With Detectable Anti-golimumab Antibodies
大体时间：At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
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Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
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At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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溃疡性结肠炎的临床试验
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Fondazione IRCCS Policlinico San Matteo di Pavia招聘中
Golimumab的临床试验
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Merck Sharp & Dohme LLC完全的
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Vastra Gotaland Region主动，不招人