NCT07609719招募中4 期
A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 24
研究概览
简要总结
The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous [IV], ocrelizumab IV) or PPMS (ocrelizumab IV).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria
- •Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)
- •Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study
- •Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy
排除标准
- •Participants who have demonstrated suboptimal response to aCD20 therapy
- •Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy
- •Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
- •Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, human papillomavirus [HPV], tuberculosis [TB])
- •History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- •Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
- •Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
- •Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
- •Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
- •Treatment with any live-attenuated vaccine within 6 weeks prior to baseline
- •Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)
- •Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone
- •Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening
- •Other protocol defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
OCR SC
Experimental
Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24.
干预措施: OCR SC (Drug)
研究者
研究点 (24)
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