tMG-E: Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: tocilizumab Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period. |
Drug: Tocilizumab Injection
Participants will receive IV tocilizumab
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events (TEAEs) [From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)]
Secondary Outcome Measures
- Change in Quantitative Myasthenia Gravis (QMG) scores. [16 weeks]
- 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 from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant has completed Study tMG.
-
Participant has given written informed consent.
-
MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study
Exclusion Criteria:
-
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;
-
Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;
-
planned thymectomy during RCP;
-
Received IVIG or plasma exchange in the past 4 weeks;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing | China | 100050 |
| 2 | Xiangya Hospital Central South University | Changsha | Hunan | China | 410008 |
| 3 | Tangdu Hospital, The Fourth Military Medical University | Xi'an | Shaanxi | China | 710038 |
| 4 | Huashan Hospital | Shanghai | Shanghai | China | 200040 |
| 5 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610041 |
| 6 | Tianjin medical university general hospital | Tianjin | Tianjin | China | 300052 |
Sponsors and Collaborators
- Tang-Du Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V1.0, 20221201