NCT05332587

Efficacy and Safety of Low-dose Rituximab in the Treatment of Refractory Myasthenia Gravis

Status unknown Phase 3 Last updated 2 May 2022

What this trial tests

Phase 3 trial testing Rituximab in Refractory Myasthenia Gravis in 50 participants. Status unknown.

Timeline

1 August 2020

Primary endpoint
1 July 2022

1 July 2022

Quick facts

Lead sponsor	First Affiliated Hospital, Sun Yat-Sen University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 August 2020
Primary completion	1 July 2022
Estimated completion	1 July 2022
Sites	1 location across China

Drugs / interventions tested

• Rituximab — full drug profile →

Conditions studied

• Refractory Myasthenia Gravis — all drugs for Refractory Myasthenia Gravis →
• Rituximab — all drugs for Rituximab →

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Who can join

Under 80, any sex, with Refractory Myasthenia Gravis or Rituximab. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to evaluate the effectiveness and safety of low-dose rituximab in patients with refractory myasthenia gravis.

The traditional treatment of MG is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70% of treated patients show an incomplete response, including 10 - 30% who are unresponsive. Corticosteroids and other immunosuppressive therapies presented also many side effects. The investigators propose to evaluate in a pilot, open, prospective, single central study, the interest of rituximab (RTX) in the treatment of patients with refractory MG. Fifty patients with refractory MG will be included in the study and divided into two stages: 14 patients in the first stage were followed up after using RTX according to the study protocol. The study will move into the second stage on if the number of effective cases is greater than 3, otherwise, the study will be discontinued (based on Simon's Optimal Two-stage Design). The remaining 36 patients were enrolled in the second stage. In the first and second stages, the treatment plan and follow-up plan were consistent. The therapeutical schema is rituximab 100-200 mg/week for a total of 2-4 times, followed by adequate organ function, laboratory parameters and assessment of MG after each injection and end of follow up for 24 weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Delving into Molecular Pathways: Analyzing the Mechanisms of Action of Monoclonal Antibodies Integrated in IMGT/mAb-DB for Myasthenia Gravis.
   Golfinopoulou R, Giudicelli V, Manso T, Kossida S. · · 2023 · cited 3× · PMID 38140161 · DOI 10.3390/vaccines11121756