An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 54
- 主要终点
- Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
研究概览
简要总结
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
详细描述
The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed the TERMS study and received at least 1 study treatment injection
- •Signed and dated statement of informed consent
排除标准
- •Pregnancy or breastfeeding
- •Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study.
- •Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments.
- •Non-compliant with TERMS study.
- •Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study.
- •Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study.
- •Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.
结局指标
主要结局
Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
时间窗: Annually
This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.
次要结局
- Evaluate Changes in Annualized Relapse Rate(Annually)
- Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression(Annually)