RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.

Sponsor
Anders Svenningsson
Study ID
NCT02746744
Phase
PHASE3
Status
Completed

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Infusion of Mabthera/Rituximab every 6 months
  • Dimethyl fumarate — DRUG
    Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
  • Sodium Chloride solution — DRUG
    Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera

Study Details

A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.

Key Dates

Start date
May 31, 2016
Status verified
Oct 2021
Primary completion
Jul 31, 2021
Completion
Aug 31, 2021

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Infusion of Mabthera/Rituximab every 6 months
  • Active Comparator: Dimethyl Fumarate
    Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
  • Sham Comparator: Sodium Chloride solution
    Sham infusion with sodium chloride solution for the Tecfidera/Dimethyl Fumarate arm every 6 months (so that the examining physician will be blinded)

Primary Outcome Measure

Freedom of relapse [ Time Frame: Within 2 years ]

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