NCT04387734进行中（未招募）4 期
Effects and Mechanisms of Ocrevus on Ambulatory Functions in People With Relapsing Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dynamic Gait Stability
研究概览
简要总结
The purpose of this study is to test if people with relapsing multiple sclerosis (RMS) can improve ambulatory functions after one-year treatment with Ocrevus in comparison with other Disease Modifying Treatments (DMT). Sixty qualified individuals with RMS will be evenly assigned into two groups: Ocrevus and other DMT. Each group will receive the respective treatment following the FDA regulations over the one-year course. Their ambulatory functions will be assessed five times three months apart. In addition, they will receive brain MRI scans three times six months apart. Their ambulatory functions and MRI measurements will be compared between groups over time to fulfill the purposes of this study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments;
- •Ages 18-65 years old at screening;
- •Clinically confirmed active, relapsing forms of MS (RMS) based on the revised McDonald criteria;
- •Can walk at least 25 feet independently with or without assistive device at screening (or the Expanded Disability Status Scale between 1 and 6.5);
- •Can stand independently for at least 30 seconds;
- •Not pregnant at screening and throughout the study;
- •No other neurological conditions and recent musculoskeletal injuries;
- •Can read and understand English;
- •No significant cognitive impairment.
排除标准
- •History of other types of MS at screening such as, primary-progressive MS);
- •Inability to complete an MRI (contraindications for MRI include but are not limited to claustrophobia, body mass greater than 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks before the time of the intended MRI, etc);
- •Patients with an active hepatitis B virus (HBV) infection;
- •Have a life-threatening allergic reaction to ocrelizumab or any of its ingredients in the past;
- •Hypersensitive to any of the ingredients of ocrelizumab;
- •Do not understand English.
- •Exclusions related to general health
- •Pregnancy or lactation;
- •Have any other known neurological diseases which may mimic MS including but not limited to: Neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis, and cerebrovascular disorders;
- •Suffering from coexisting psychiatric disorders, neurological disorders, or severe medical illness;
- •Current severe depression and/or suicidal ideation;
- •Significant cognitive impairment (Montreal Cognitive Assessment score < 24);
- •New onset, unstable orthopedic comorbid diagnoses (within 3 months and uncontrolled);
- •History or currently active primary or secondary immunodeficiency;
- •Receipt of a live vaccine within 6 weeks prior to baseline;
- •Skin is allergic to transparent double-side tapes;
- •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study;
- •History or currently active primary or secondary immunodeficiency;
- •Lack of peripheral venous access;
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
- •Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study;
- •Congestive heart failure (NYHA III or IV functional severity);
- •Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds;
- •Infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit;
- •History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis, tuberculosis);
- •History of progressive multifocal leukoencephalopathy (PML);
- •History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins;
- •History of alcohol or drug abuse within 24 weeks prior to baseline;
- •History or laboratory evidence of coagulation disorders;
- •Exclusions related to medications
- •Receipt of a live vaccine within 6 weeks prior to baseline;
- •Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer);
- •Contraindications to or intolerance of oral or intravenous corticosteroids, including methylprednisolone administered intravenous, according to the country label, including:
- •Psychosis not yet controlled by a treatment;
- •Hypersensitivity to any of the constituents;
- •Treatment with dalfamipridine (Ampyra®) unless on stable dose for ≥ 30 days prior to screening. Patients should remain on stable doses throughout the 52-week treatment period;
- •Previous treatment with B-cell targeted therapies (i.e. rituximab, ocrelizumab, atacicept, belimumab or ofatumumab);
- •Systemic corticosteroid therapy within 4 weeks prior to screening;
- •Any previous treatment with alemtuzumab (Campath), anti-CD4, cladribine, mitoxantrone, daclizumab, BG12, teriflunomide, laquinimod, total body irradiation or bone marrow transplantation;
- •Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil (MMF), cyclosporine, methotrexate, or natalizumab within 24 months prior to screening;
- •Treatment with intravenous immunoglobulin within 12 weeks prior to baseline.
- •Exclusions related to motor function
- •Cannot walk at least 25 feet and stand at least 30 seconds independently;
- •Weak or blind vision may impair their ability of walking;
- •Exclusions related to musculoskeletal, cardiovascular, and orthopedic condition
- •Broken bones as an adult in the past year;
- •Have received neurological treatment, such as Botox, in the past six months;
- •Heart attack, angioplasty, or coronary artery bypass graft in the past six months;
- •Congestive heart failure (NYHA III or IV functional severity);
- •Surgery on back, hip, shoulder, or total joint replacement of hip or knee joint less than two years ago;
- 另有 11 项未显示
研究组 & 干预措施
Other Disease Modifying Treatments
Active Comparator
Other Disease Modifying Treatments will consist of FDA-approved injectable and oral medications for multiple sclerosis.
干预措施: Platform (Drug)
Ocrevus
Experimental
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Dynamic Gait Stability
时间窗: 12 months
To quantify dynamic balance of participants during level walking.
次要结局
- Step width(12 months)
- Swing index(12 months)
- Gait speed(12 months)
- Cadence(12 months)
- Stability index(12 months)
- Step length(12 months)
- Step time(12 months)
- Lower limb muscle strength(12 months)
- Lower limb muscle activity(12 months)
- Multiple Sclerosis Functional Composite(12 months)
- Expanded Disability Status Scale(12 months)
- Total cerebral T2 lesion volume(12 months)
- Prospective falls(12 months)
研究者
Feng Yang, PhD
Associate Professor
Georgia State University
研究点 (2)
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