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Recruiting NCT05067348

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

Phase II Interventional Myasthenia Gravis, Generalized

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tocilizumab Injectable Product.
Who it may be relevant to
Registry conditions: Myasthenia Gravis, Generalized. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

This study is a randomized, double-blind, placebo-controlled study, to be conducted at 6 study sites. Approximately 64 subjects will be enrolled. Patients with MG who are positive for anti-AChR antibodies will be enrolled. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score ≥ 5, QMG score ≥ 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.

All subjects who complete the randomized controlled period will have the option to enroll in a 1-year open-label period.

Interventions

  • Drug Tocilizumab Injectable Product
    Participants will receive IV tocilizumab

Primary outcome measures

  • Change in Quantitative Myasthenia Gravis (QMG) scores. [Time frame: 16 weeks]
Secondary outcome measures (7)
  • Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks [Time frame: 16 weeks]
  • Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks [Time frame: 16 weeks]
  • Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score. [Time frame: 16 weeks]
  • Change in Myasthenia Gravis Composite (MGC) score [Time frame: 16 weeks]
  • Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score. [Time frame: 16 weeks]
  • Change in Myasthenia Gravis Impairment Index (MGII) score. [Time frame: 16 weeks]
  • Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the randomized controlled period and open-label period. [Time frame: 16 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 6 centers
  • Beijing Tiantan Hospital, Capital Medical University — Beijing
  • Xiangya Hospital Central South University — Changsha
  • Tangdu Hospital, The Fourth Military Medical University — Xi'an
  • Huashan Hospital — Shanghai
  • West China Hospital of Sichuan University — Chengdu
  • Tianjin medical university general hospital — Tianjin

Identifiers

NCT: NCT05067348 · V4.0, 20220410

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗