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

ConditionMyasthenia Gravis, Generalized
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tocilizumab Injectable Product

    Drug

    Participants will receive IV tocilizumab

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: TocilizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Quantitative Myasthenia Gravis (QMG) scores.

Time frame
16 weeks

Secondary outcomes

1

Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks

Time frame
16 weeks
2

Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks

Time frame
16 weeks
3

Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score.

Time frame
16 weeks
4

Change in Myasthenia Gravis Composite (MGC) score

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov
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