EUCTR2021-005746-15-LT招募中1 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)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,107
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Prior eligibility for and previous participation in 1 of the Roche-sponsored 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1033
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •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
相似试验
招募中
1 期
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients with Multiple SclerosisMultiple Sclerosis (MS)MedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosis Class: 100000004852CTIS2023-505974-14-00F. Hoffmann-La Roche AG1,917
进行中（未招募）
1 期
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients with Multiple SclerosisEUCTR2021-005746-15-HUF. Hoffmann-La Roche Ltd1,300
进行中（未招募）
1 期
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients with Multiple SclerosisEUCTR2021-005746-15-NOF. Hoffmann-La Roche Ltd1,107
进行中（未招募）
1 期
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients with Multiple SclerosisPrimary Progressive Multiple Sclerosis (PPMS)Relapsing Multiple Sclerosis (RMS)MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2021-005746-15-DEF. Hoffmann-La Roche Ltd1,107
进行中（未招募）
1 期
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients with Multiple SclerosisPrimary Progressive Multiple Sclerosis (PPMS)Relapsing Multiple Sclerosis (RMS)MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2021-005746-15-SKF. Hoffmann-La Roche Ltd1,107