Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab
研究概览
简要总结
Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients will be treated with ocrelizumab at disease onset to see if treatment favorably alters CSF markers of chronic inflammation.
详细描述
Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients age 18-50 will be treated with ocrelizumab within 90 days of first clinical MS/CIS presentation and re-dosed as maintenance therapy every 6 months for 3 years to see if treatment favorably alters CSF markers of chronic inflammation
Investigators hope data that will provide a foundation for further studies that treating relapsing MS patients at clinical onset (using a B-cell depleting therapy) may improve longer-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the following criteria to be included in this study:
- •Signed Consent Form
- •High-risk clinically isolated syndrome or relapsing MS Diagnosis (based on 2017 International Panel Criteria)
- •Age 18-50 inclusive
- •Screening within 90 days of first clinical demyelinating event typical of MS with 1 or more inactive lesions typical of MS
- •No prior MS disease modifying therapy
- •No corticosteroids within 7 days of first ocrelizumab treatment
- •EDSS < 4.0
- •A negative urine or serum pregnancy test must be available for premenopausal women and for women <12 months after the onset of menopause, unless they have undergone surgical sterilization.
- •Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use one method of contraception with a failure rate of <1% per year or a barrier method supplemented with spermicide. Contraception must continue for the duration of study treatment and for at least 24 weeks after the last dose of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause of other than menopause), and has not undergone surgical sterilization (removal of the ovaries and/or uterus).
- •Examples of contraceptive methods with a failure rate of <1% per year include bilateral tube ligation, male sterilization, established hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- •The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception.
- •Examples of barrier methods supplemented with the use of spermicide include male or female condom, cap, diaphragm, or sponge.
排除标准
- •Patients will be excluded from the study based on the following criteria:
- •Pregnancy, lactation, or intention to become pregnant during the study
- •Progressive MS (primary or secondary)
- •Disease other than MS to explain the first demyelinating event; including AQP4 IgG seropositivity
- •Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator
- •Unwilling or unsafe to proceed with MRI
- •Active hepatitis B virus infection
- •Untreated latent or active tuberculosis
- •Active hepatitis C virus infection
- •HIV infection
- •Hypersensitivity to trial medications
- •History of life-threatening infusion reaction to MAbs
研究组 & 干预措施
Ocrelizumab treated
Participants age 18-50 with a first clinical presentation of MS or high-risk CIS diagnosed within 90 days of screening will be treated with ocrelizumab (300 mg IV x 2 doses given 2 weeks apart) at disease origin and with maintenance ocrelizumab 600 mg every 6 months through 30 months with a final study visit at 3 years
干预措施: Ocrelizumab (Drug)
Observational study cohort
Subjects enrolled into an observational study matched for the same disease duration and who are either untreated or treated with alternate MS disease modifying therapies will serve as a parallel reference group
结局指标
主要结局
Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab
时间窗: 3 years
Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after 3 years of treatment with ocrelizumab. Intrathecal synthesis is measured by either a) normalization of the IgG Index (0.6 is the upper limit of normal) or b) eradication of oligoclonal bands
次要结局
未报告次要终点