跳至主要内容
临床试验/NL-OMON55946
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

发起方
F. Hoffman-La Roche Ltd

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