Myasthenia Gravis, Generalized Clinical Trial
— tMG-EOfficial title:
A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)
Verified date | January 2024 |
Source | Tang-Du Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Recruiting |
Enrollment | 64 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing |
China | Xiangya Hospital Central South University | Changsha | Hunan |
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
China | Huashan Hospital | Shanghai | Shanghai |
China | Tianjin medical university general hospital | Tianjin | Tianjin |
China | Tangdu Hospital, The Fourth Military Medical University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment-emergent adverse events (TEAEs) | From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks) | ||
Secondary | Change in Quantitative Myasthenia Gravis (QMG) scores. | 16 weeks | ||
Secondary | Proportion of subjects with both (1) = 3-point improvement in QMG and (2) lasts =4 weeks | 16 weeks | ||
Secondary | Proportion of subjects with both (1) = 2-point improvement in MG-ADL and (2) lasts =4 weeks | 16 weeks | ||
Secondary | Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score | 16 weeks | ||
Secondary | Change in Myasthenia Gravis Composite (MGC) score | 16 weeks | ||
Secondary | Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score. | 16 weeks |
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