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: 25 Aug 2017

At a glance

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

    • 25 Aug 2017 According to a Merck & Co 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 European Commission (EC) has granted marketing authorization for MAVENCLAD 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis (RMS) in the 28 countries of the European Union (EU).
    • 23 Jun 2017 According to a Merck & Co media release, the CHMP's recommendation will be referred to the European Commission which is expected to make a final decision on the marketing authorisation application for Cladribine Tablets within 67 days from the CHMP opinion.
    • 23 Jun 2017 According to a Merck & Co 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Cladribine Tablets for the treatment of relapsing forms of multiple sclerosis (RMS) in patients with high disease activity.
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