Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.
详细描述
This was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously (IV) every 8 weeks. The study population included treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants, as well as 38 UC participants who had tolerated vedolizumab well during Study C13002 (NCT01177228).
In the original study protocol, all participants were randomized to receive vedolizumab at doses of either 6 mg/kg or 10 mg/kg. With the implementation of Amendment 1, the assigned doses of vedolizumab were decreased to 2.0 mg/kg and 6.0 mg/kg. To implement the dose changes, instead of randomizing all participants across both doses, those who rolled over from Study C13002 were reassigned to receive the 2.0 mg/kg dose and all participants who entered C13004 naïve to treatment were to receive the 6.0 mg/kg dose, starting on the next scheduled dosing day. Also, if participants assigned to the 2 mg/kg dose experienced flare, they were to receive the higher 6 mg/kg dose.
In the results analyses for this study, participants are grouped according to the lowest dose received, i.e., 2.0 mg/kg or 6.0 mg/kg vedolizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD)
- •Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD
- •Partial Mayo score of 2 - 7 for participants with UC
- •Patient should be appropriate candidate for biologic therapy per guidelines
- •Up-to-date on cancer screening
- •No severe systemic disease
- •Patients with evidence of abscess
- •Agree to comply with study procedures including contraception
排除标准
- •Low lymphocyte counts
- •History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other neurological illness
- •Active or recent serious infections
- •Recent treatment with biologic (i.e., Remicade) or investigational drug
- •Impending surgery
- •Any participants with vedolizumab human anti-human antibody (HAHA) titers ≥1:125 or with a previous immediate hypersensitivity reaction during or shortly after vedolizumab infusion
研究组 & 干预措施
Vedolizumab 2 mg/kg
Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks.
干预措施: vedolizumab (Drug)
Vedolizumab 6 mg/kg
Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks.
干预措施: vedolizumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From Day 1 to Day 637
An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities.
Number of Participants With Clinically Significant Laboratory Findings
时间窗: through Day 637
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.
Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)
时间窗: through Day 637
At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.
Number of Participants With Human Anti-human Antibodies (HAHA)
时间窗: Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.
次要结局
- Serum Concentration of Vedolizumab Before Dosing(Days 43, 99, 155 and 267, predose)
- Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay(Days 43, 99, 155 and 267, predose)
- Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay(Days 43, 99, 155 and 267, predose)