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: 23 Jun 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

    • 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.
    • 10 Jun 2017 Biomarkers information updated
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