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A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis

NCT02950155 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-10-26

Study results available
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Summary

A randomized, double-blind, placebo-controlled multicenter study evaluating the safety and efficacy of Rituximab (Mabthera®) in patients with new onset generalized myasthenia gravis (MG).

Conditions

Interventions

DRUG

Rituximab

A single infusion at a dose of 500 mg Mabthera/Rituximab.

DRUG

Sodium Chloride solution

A single infusion of Placebo/Sham.

Sponsors & Collaborators

  • Fredrik Piehl

    lead OTHER

Principal Investigators

  • Fredrik Piehl, Professor · Dept Clinical Neuroscience Karolinska Institutet, Neuroimmunology Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-16
Primary Completion
2021-01-30
Completion
2022-01-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

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 NCT02950155 on ClinicalTrials.gov