Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTang-Du Hospital

About this trial

Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.

Eligibility criteria

Qualifiers

Diagnosis of MG with anti-AChRantibody.

MGFA Clinical Classification Class II, III, or IV.

MG-ADL score of 5 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.

QMG score of 11 or greater.

Disqualifiers

Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the 4 weeks before randomization;

Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;

Human immunodeficiency virus (HIV) infection;

Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time;

Trial design

Treatments tested in this trial

  • Tocilizumab Injectable Product

Treatment groups

64 Participants
are divided into 2 treatment groups

Locations

6
Beijing Tiantan Hospital, Capital Medical University100050, BeijingBeijing Municipality, China
Xiangya Hospital Central South University410008, ChangshaHunan, China
Tangdu Hospital, The Fourth Military Medical University710038, Xi'anShaanxi, China
Huashan Hospital200040, ShanghaiShanghai Municipality, China

Sponsors and collaborators

Tang-Du Hospital

Lead sponsor