2025-523726-40-00招募中3 期
A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 27
研究概览
简要总结
To evaluate the suitability of the on-body delivery system (OBDS) for high concentration (HC) subcutaneous (SC) ocrelizumab administration by the participant or their lay caregiver
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years at the time of signing Informed Consent Form
- •Willing and able to receive injections using the OBDS, as either a self-injection or administered by a lay caregiver For participants who are willing to complete self-injection: deemed by the healthcare provider to be able to do the injection based on motor and cognitive function
- •For female participants of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab
- •For female participants without childbearing potential: Female participants may be enrolled if postmenopausal
- •Currently being treated with ocrelizumab: At least one prior dose of ocrelizumab 600 mg IV or 920 mg SC Note: The first dose of ocrelizumab in this study will be administered approximately 6 months (± 1 month) after a previous (pre-study) ocrelizumab dose (and may not be administered earlier than 5 months after the last pre-study ocrelizumab dose)
- •Diagnosis of MS according to the revised McDonald 2024 criteria (Montalban et al. 2025) or the most current published revision of the McDonald criteria at the time of study start
排除标准
- •Participant does not have reliable and consistent access to communication (e.g., telephone/mobile phone)
- •Participant resides in a location that, in the investigator's opinion, does not allow for timely access to an emergency medical facility
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
- •Sensitivity or intolerance to acrylic
研究组 & 干预措施
Ocrevus, Ocrelizumab
Test
干预措施: Ocrevus, Ocrelizumab (Drug)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (27)
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