Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis (tMG-E)

Tang-Du Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Myasthenia Gravis, Generalized

Treatments: Drug: Tocilizumab Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05716035

V1.0, 20221201

Details and patient eligibility

About

To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).

Full description

tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG.

After receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG.

Study tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant has completed Study tMG.
2. Participant has given written informed consent.
3. MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study

Exclusion criteria

1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the past 4 weeks;
2. Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;
3. planned thymectomy during RCP;
4. Received IVIG or plasma exchange in the past 4 weeks;
5. Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

tocilizumab

Experimental group

Description:

Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.

Treatment:

Drug: Tocilizumab Injection