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ClinicalTrial.gov Identifier : NCT03737851

A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis

    Status Recruiting
    Related Conditions
    Multiple Sclerosis

Enrollment Details

165 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M18-918

Brief summary

Top

The purpose of this study is to evaluate the safety and efficacy of elezanumab in subjects with relapsing Multiple Sclerosis (RMS).

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 55 Years

Canada: 8

0
Vancouver, BC
1
Halifax, NS
2
Hamilton, ON
3
London, ON
4
Ottawa, ON
5
Toronto, ON
6
Montreal, QC
7
Montreal, QC
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Study Design

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double (Participant/Investigator)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Subject has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months
    • Subject has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS)
    • Subject has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test
    • Subjects must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening

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