Myasthenia Gravis, Generalized
Conditions
Keywords
Generalized Myasthenia Gravis, Tocilizumab, Open-label
Brief summary
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).
Detailed 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.
Interventions
Participants will receive IV tocilizumab
Sponsors
Tang-Du Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks | 16 weeks |
| Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks | 16 weeks |
| Change in Quantitative Myasthenia Gravis (QMG) scores. | 16 weeks |
| Change in Myasthenia Gravis Composite (MGC) score | 16 weeks |
| Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score. | 16 weeks |
| Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score | 16 weeks |
Countries
China
Outcome results
None listed