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

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

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Jul 2018

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

    • 30 Jul 2018 According to a Merck KGaA media release, based on the data from three Phase III trials (CLARITY, CLARITY EXTENSION and ORACLE MS) and a phase II trial (ONWARD) including long term data from PREMIERE study, the US FDA has accepted the New Drug Application (NDA) for cladribine tablets, after the resubmission of an application, as a potential treatment for patients with relapsing forms of multiple sclerosis (MS).
    • 19 Jun 2018 Results (n=1067) of pooled analysis of CLARITY andf ONWARD trials presented at the 4th Congress of the European Academy of Neurology.
    • 19 Jun 2018 Results of post hoc analysis from ONWARD trial presented at the 4th Congress of the European Academy of Neurology
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