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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05716035
Other study ID # V1.0, 20221201
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 1, 2023
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Tocilizumab Injection
Participants will receive IV tocilizumab

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

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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