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EFG vs IVIG in TAMG

ConditionsEfgartigimodIntravenous ImmunoglobulinMyasthenia Gravis Associated With Thymoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor (AChR) antibody-positive thymoma patients with myasthenia gravis in order to provide reliable evidence for clinical decision-making.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged >18 years and ≤75 years, with an expected survival time >12 months;

Patients with generalized myasthenia gravis;

MG-ADL ≥6;

Positive for AChR antibody;

Disqualifiers

MGFA type V;

Patients who have undergone median sternotomy;

Confirmed history of congestive heart failure; poorly controlled angina pectoris with drug treatment; electrocardiogram (ECG) confirmed transmural myocardial infarction; poorly controlled hypertension; clinically significant valvular heart disease; or high-risk uncontrolled arrhythmia;

Patients with weight loss of more than 5kg in the past month; severe uncontrolled systemic disease, such as active infection or poorly controlled diabetes; patients with hemorrhagic diseases and bleeding tendencies; coagulation dysfunction, bleeding tendency or receiving thrombolytic or anticoagulant therapy; patients with grade II-IV bone marrow suppression;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Efgartigimod + Thymectomy

    Combination product

    Patients receive weight-based EFG infusions (10 mg/kg; fixed 1200 mg for ≥120 kg) administered over 1 hour once weekly for 4 total doses. If a scheduled infusion is missed, EFG may be administered within 48 hours of the planned time, followed by resumption of the original schedule to complete all 4 infusions. Thymectomy is performed on the day following the second EFG infusion with a permitted ±3-day surgical window.

  • Intravenous immunglobulin + Thymectomy

    Combination product

    Patients receive weight-based IVIG infusions (400 mg/kg) administered daily for 5 consecutive days. Thymectomy is performed approximately 7 days after completing the final IVIG infusion, with a permitted ±3-day surgical window.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Efgartigimod + ThymectomyExperimental treatment 1 intervention
Group B: Intravenous immunglobulin + ThymectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quantitative Myasthenia Gravis (QMG) reduction

The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.

Time frame
From baseline to 2 weeks postoperatively

Secondary outcomes

1

Myasthenia Gravis Activities of Daily Living (MG-ADL) reduction

The total MG-ADL score ranges from 0 to 24, with higher scores indicating more severe condition

Time frame
From baseline to 2 weeks postoperatively
2

Myasthenia Gravis Composite (MGC) reduction

The total MGC score ranges from 0 to 50, with higher scores indicating more severe condition.

Time frame
From baseline to 2 weeks postoperatively
3

QMG change (1 day preoperatively)

The change in the QMG score from baseline to 1 day preoperatively

Time frame
From baseline to 1 day preoperatively
4

QMG change (1 week postoperatively)

The change in the QMG score from baseline to 1 week postoperatively

Time frame
From baseline to 1 week postoperatively

Other outcomes

Sponsors and contacts

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

Shanghai Zhongshan Hospital

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Tang-Du Hospital

Collaborator

West China Hospital

Collaborator

Second Affiliated Hospital of Soochow University

Collaborator

Huashan Hospital

Collaborator

The Affiliated Brain Hospital of Nanjing Medical University

Collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Collaborator

Wuhan TongJi Hospital

Collaborator

Source ClinicalTrials.gov

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