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RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.

NCT02746744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-12

No results posted yet for this study

Summary

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

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Rituximab

Infusion of Mabthera/Rituximab every 6 months

DRUG

Dimethyl fumarate

Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.

DRUG

Sodium Chloride solution

Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera

Sponsors & Collaborators

  • Anders Svenningsson

    lead OTHER

Principal Investigators

  • Anders Svenningsson, MD, PhD · Dept.of Medicine, Sect.of Neurology, Danderyd Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-07-31
Completion
2021-08-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02746744 on ClinicalTrials.gov