NL-OMON55946招募中3 期
A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis - OLERO (Open-Label Extension Roll Over)
F. Hoffman-La Roche Ltd0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64(—)
入选标准
- •Prior eligibility for and previous participation in 1 of the Rochesponsored
- •Parent Studies WA21092, WA21093, or WA25046 with the participant either
- •receiving ocrelizumab as an investigational medicinal product (IMP) or being in
- •safety follow-up after treatment discontinuation
- •For female participants of childbearing potential: agreement to remain
- •abstinent (refrain from heterosexual intercourse) or use adequate acceptable
- •contraception during the treatment period and for at least 6 months or longer
- •if the local label is more stringent after the final dose of ocrelizumab, as
- •applicable in the ocrelizumab package leaflet
排除标准
- •Potential participants are excluded from the study if any of the following
- •criteria apply:
- •Concurrent participation in any clinical trial (other than the Parent study)
- •Unable or unwilling to comply with the requirements of the protocol
研究者
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