跳至主要内容
临床试验/CTRI/2021/03/031904
CTRI/2021/03/031904进行中(未招募)3 期

A phase III multicenter, randomized,double-blind, double-dummy,parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with teriflunomide in adult patients with relapsing multiple sclerosis

F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
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

  • Informed Consent
  • Woman or man age 18-55 years inclusive
  • EDSS score of 0-5.5 at screening
  • Neurologically stable for at least 30 days prior to randomization and baseline assessments
  • Ability to complete the 9-HPT for each hand in 240 seconds
  • Ability to perform the T25FWT

排除标准

  • Disease duration of >10 years from the onset of symptoms and an EDSS score at screening <2.0
  • Pregnant or breastfeeding
  • A diagnosis of PPMS or non-active SPMS

研究者

发起方
F HoffmannLa Roche Ltd

相似试验

进行中(未招募)
不适用
A phase III multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group study of the efficacy and safety of oral netupitant administered in combination with palonosetron and dexamethasone compared to oral palonosetron and dexamethasone for the prevention of nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy
EUCTR2009-016775-30-HUHelsinn Healthcare SA1,460
进行中(未招募)
不适用
This is a study assessing efficacy and safety of a single oral dose of a fixed combination of netupitant and palonosetron (300/0.5 mg), two antiemetic drugs, versus oral palonosetron 0.5 mg, both given with oral dexamethasone. The objective of the study is to demonstrate that the fixed dose combination is more effective of palonosetron alone, to prevent nausea and vomiting induced by repeated cycles of certain chemotherapyausea and vomiting in cancer patients receiving moderately emetogenic theraphyMedDRA version: 14.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures
EUCTR2009-016775-30-ITHelsinn Healthcare SA1,460
尚未招募
3 期
The study assesses efficacy and safety of a single oral dose of a fixed combination of netupitant/palonosetron 300/0.5 mg vs oral palonosetron 0.5 mg, both with oral dexamethasone, to demonstrate the combination is more effective of palonosetron alone in preventing nausea/vomiting by chemotherapy.
CTRI/2011/12/002296Helsinn Healthcare SA1,460
进行中(未招募)
不适用
A phase III multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group study of the efficacy and safety of oral netupitant administered in combination with palonosetron and dexamethasone compared to oral palonosetron and dexamethasone for the prevention of nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapyausea and vomiting in cancer patients receiving moderately emetogenic theraphyMedDRA version: 14.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures
EUCTR2009-016775-30-PLHelsinn Healthcare SA1,460
进行中(未招募)
不适用
This is a study assessing efficacy and safety of a single oral dose of a fixed combination of netupitant and palonosetron (300/0.5 mg), two antiemetic drugs, versus oral palonosetron 0.5 mg, both given with oral dexamethasone. The objective of the study is to demonstrate that the fixed dose combination is more effective of palonosetron alone, to prevent nausea and vomiting induced by repeated cycles of certain chemotherapy.ausea and vomiting in cancer patients receiving moderately emetogenic theraphyMedDRA version: 14.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures
EUCTR2009-016775-30-BGHelsinn Healthcare SA1,460