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

Sponsor
Fredrik Piehl
Study ID
NCT02950155
Phase
PHASE3
Status
Completed

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    A single infusion at a dose of 500 mg Mabthera/Rituximab.
  • Sodium Chloride solution — DRUG
    A single infusion of Placebo/Sham.

Study Details

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).

Key Dates

Start date
Oct 16, 2016
Status verified
Aug 2024
Primary completion
Jan 30, 2021
Completion
Jan 31, 2022

Study Design

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

Arms

  • Experimental: Rituximab
    A single infusion at a dose of 500 mg of Mabthera/Rituximab.
  • Sham Comparator: Sodium Chloride solution
    A single infusion with sodium chloride solution.

Primary Outcome Measure

Percentage of Patients With Quantitative MG Score (QMG) Score ≤ 4 and a Daily Prednisolon Dose of ≤ 10mg at 16 Weeks After Administration of Study Drug/Placebo. [ Time Frame: 16 weeks ]

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