A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Parallel-group Study Evaluating the Efficacy and Safety of Golimumab Administered Subcutaneously in Symptomatic Subjects With Severe, Persistent Asthma
研究概览
详细说明
Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of severe, persistent asthma.This study will assess the safety and effectiveness of subcutaneously (under the skin) administered golimumab and determine if there is a reduction of signs and symptoms in patients with active severe, persistent asthma. The effect of subcutaneously (SC) administered golimumab on the quality of life in patients with severe, persistent asthma will also be assessed. About 200 patients will take part in the study at approximately 60 centers worldwide. Participation in the study will last for about 42 weeks. The study consists of 3 phases: the screening phase (lasting between 1 and 4 weeks), the treatment phase (20 weeks), and the follow-up phase (20 weeks). Visits are scheduled to occur once every 4 weeks during the treatment and follow-up phases of the study. Patients eligible to take part in this study will be randomly placed into one of the following study groups: Group 1: Placebo (an inactive or dummy treatment that looks the same as the study drug, golimumab, but does not contain any active medication) from Week 0 through Week 20. Group 2: Golimumab 100 mg from Week 0 through Week 20. This study is "blinded." This means that neither patient nor study doctor will know in which group a patient is placed. However, if needed for safety or health reasons, the study doctor can find out a patient's study group at any time.
Patients will receive an injection (under the skin) of placebo (Group 1) or golimumab 100 mg (Group 2) every 4 weeks from Week 0 through Week 20.
研究类型
阶段
- 阶段2
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:
- Physician diagnosis of asthma for >= 3 years and a diagnosis of severe, persistent asthma for >= 1 year prior to screening
- Reversible airway obstruction
- Continuous treatment with high dose inhaled corticosteroids and long-acting Beta2-agonist for at least 3 months prior to screening
- At least 1 occasion in the previous 6 months when worsening of asthma required treatment with additional steroids (intravenous or oral)
- Score of >= 2 points on the Asthma Control Questionnaire (ACQ) at screening
Exclusion Criteria:
- Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder
- Life-threatening asthma attack requiring intubation in the 6-month period prior to screening
- Steroid use at a dose > 20 mg of prednisone at the screening visit
- Known malignancy or history of malignancy
- Previous exposure to anti-TNF therapies
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：001
|
100 mg sc injection every 4 weeks from week 0 to week 20
|
|
安慰剂比较：002
|
placebo sc injection every 4 weeks from week 0 to week 20
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The primary endpoint is the time to first severe asthma exacerbation through Week 24.
大体时间：Week 24
|
Week 24
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Secondary endpoints include the number of severe asthma exacerbations through Week 24, number of clinically significant asthma exacerbations through Week 24, and change from baseline in Asthma Quality of Life Questionnaire (AQLQ) overall score at Week 24
大体时间：Week 24
|
Week 24
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
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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