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A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-β) Treatment in Multiple Sclerosis Subjects With Active Disease

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Trial Profile

A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-β) Treatment in Multiple Sclerosis Subjects With Active Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Cladribine (Primary) ; Interferon beta-1b; Interferon beta-1b
  • Indications Multiple sclerosis
  • Focus Adverse reactions
  • Acronyms ONWARD
  • Sponsors EMD Serono; Merck Serono

    • Most Recent Events

    • 28 Nov 2020 Results of pooled analysis (data pooled from CLARITY, CLARITY EXTENSION ORACLE-MS and ONWARD studies ) assessing the development of Cladribine tablets for the treatment of Multiple Sclerosis published in the Drugs
    • 25 Mar 2019 According to a Merck media release, based on data from the clinical development program which includes data from three placebo-controlled Phase III trials, CLARITY (pivotal efficacy study), CLARITY EXTENSION and ORACLE MS, the Phase II ONWARD study and long-term follow-up data from the 8-year prospective registry, PREMIERE, the Swissmedic has approved MAVENCLAD (cladribine tablets) for the treatment of highly active relapsing remitting multiple sclerosis (RRMS) in Switzerland.
    • 10 Oct 2018 According to a Merck KGaA media release, additional post-hoc data were presented at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS) 2018.
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