Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Modulation of One or All Paramagnetic Rim Lesions
研究概览
简要总结
Background:
Multiple sclerosis (MS) is a disease of the central nervous system (CNS). People who have MS may have lesions that form on parts of the CNS, such as the brain. Some of these lesions may be inflamed for a long time. This causes MS to progress. There is no treatment for these lesions. Researchers believe that a drug that decreases inflammation can help.
Objective:
To see if a drug called anakinra can help clear inflammation in MS brain lesions.
Eligibility:
People 18 and older with MS and at least one white matter lesion.
Design:
Participants will be screened with one or more Neuroimmunology Clinic protocols.
Participants will have a medical history and physical exam. They will have blood and urine tests. They will have a lumbar puncture. For this, a needle is inserted between the bones in the back, and cerebrospinal fluid is removed. They will also have an MRI of the brain. The MRI scanner is a cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the scanner.
Participants will repeat the above procedures throughout the study.
Participants will get their first dose of anakinra at the clinic. They will administer the rest of the doses themselves, by injection under the skin.
Participants will track their daily dosage electronically or in a written drug diary.
Participants will have 4 visits while taking the drug. At each visit, sharps boxes and empty vials will be collected.
Participants will have 2 follow-up visits after completing treatment.
The study will last 28 weeks.
详细描述
Objective:
The overall goal of this study is to determine the safety, tolerability, and radiological efficacy of up to 12 weeks of subcutaneous injection of anakinra in people with multiple sclerosis and evidence, by magnetic resonance imaging (MRI), of chronic active (also known as smoldering ) lesions in the white matter.
Study population:
5 people with progressive or stable MS, at least one paramagnetic rim lesion on 7-tesla MRI, and no new white matter lesion formation for at least 3 months or clinical relapse for at least 12 months, will complete the study.
Design:
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1/Active treatment
Patients with MS will be assigned to the same intervention
干预措施: Anakinra (Drug)
结局指标
主要结局
Modulation of One or All Paramagnetic Rim Lesions
时间窗: 24 weeks
Proportion of lesions in which the paramagnetic rim has been modulated at the end of the dosing period.
次要结局
- Change in the 9-hole Peg Test (9HPT)(24 weeks)
- Change in the Symbol Digit Modalities Test (SDMT)(24 weeks)
- Change in the Expanded Disability Status Scale (EDSS)(24 weeks)
- Change in Paramagnetic Rim Lesion at Any Time Point(Up to 24 weeks)
- Change in Size of Paramagnetic Rim Lesions at All Time Points, Relative to Non-rim Lesions(Every 4 weeks for the duration of the study)
- Changes in T1 Relaxation Time Within Paramagnetic Rim Lesions at All Time Points, Relative to Non-rim Lesions(Every 4 weeks for the duration of the study)