Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05067348

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

Led by Tang-Du Hospital · Updated on 2025-05-01

64

Participants Needed

6

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of myasthenia gravis with anti-AChR antibody
  • MGFA Clinical Classification Class II, III, or IV
  • MG-ADL score of 5 or greater at screening and randomization, with over 50% due to non-ocular symptoms
  • QMG score of 11 or greater
  • Use of cholinesterase inhibitor with no dose increase in 4 weeks before randomization
  • Use of corticosteroids with no dose increase in 4 weeks before randomization
  • Use of non-steroidal immunosuppressant for at least 6 months with no dose increase in 4 months before randomization
Not Eligible

You will not qualify if you...

  • Active or severe infections in the 4 weeks before randomization
  • History of high-risk or acquired tuberculosis infection, or chronic hepatitis
  • Human immunodeficiency virus (HIV) infection
  • Thymomas with recent or planned thymectomy within 6 months before randomization, or requiring chemotherapy or radiotherapy
  • Rituximab treatment in the past 6 months before randomization
  • Tocilizumab or eculizumab treatment within 3 months before randomization
  • Intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks before randomization
  • Unresected thymoma
  • History of other tumor diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100050

Not Yet Recruiting

2

Xiangya Hospital Central South University

Changsha, Hunan, China, 410008

Not Yet Recruiting

3

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, China, 710038

Actively Recruiting

4

Huashan Hospital

Shanghai, Shanghai Municipality, China, 200040

Not Yet Recruiting

5

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

Not Yet Recruiting

6

Tianjin medical university general hospital

Tianjin, Tianjin Municipality, China, 300052

Not Yet Recruiting

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Research Team

T

Ting Chang, MD,PHD

CONTACT

Z

Zhe Ruan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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