PER-003-19已完成未知
AN OPEN-LABEL, SINGLE ARM, MULTI-CENTER EXTENSION STUDY EVALUATING LONG-TERM SAFETY, TOLERABILITY AND EFFECTIVENESS OF OFATUMUMAB IN SUBJECTS WITH RELAPSING MULTIPLE SCLEROSIS (RMS)
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2019年5月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
入选标准
- •Must have participated in a Novartis MS study:
- •which dosed ofatumumab 20 mg sc every 4 weeks,
- •was an adult (≥ 18 years of age) study in RMS,
- •must have completed the study on study treatment (subjects that are on temporary drug interruption at the time of End of Study are considered completers).
排除标准
- •1. Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study
- •2. Subjects that have had their previous ofatumumab study EOS > 6 months prior to screening and/or been given another MS DMT between EOS of previous study and screening of this study
- •3. Less than 3.5-month washout of teriflunomide for subjects that will not complete the AEP prior to Day 1 (refer to Section 6.6.1.1). Only applicable to subjects completing studies COMB157G2301 and COMB157G2302
研究者
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