RecruitingPhase 2NCT05067348

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

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Sponsor

Tang-Du Hospital

Enrollment

64 participants

Start Date

Jul 21, 2022

Study Type

INTERVENTIONAL

Conditions

Myasthenia Gravis, Generalized

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

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.
Subjects must be on:
Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;
Corticosteroids, with no dose increase within 4 weeks prior to randomization; or/and c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.

Exclusion Criteria9

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;
Received rituximab treatment in the past 6 months before randomization;
Received tocilizumab or eculizumab treatment within 3 months before randomization;
Received IVIG or plasma exchange within 4 weeks before randomization;
Unresected thymoma.
History of other tumor diseases.

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Interventions

DRUGTocilizumab Injectable Product

Participants will receive IV tocilizumab

Locations(6)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, China

Huashan Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin medical university general hospital

Tianjin, Tianjin Municipality, China

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NCT05067348

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