Back to resultsOpen-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis (tMG-E)
Primary Purpose
Myasthenia Gravis, Generalized
Status
Enrolling by invitation
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tocilizumab Injection
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis, Generalized focused on measuring Generalized Myasthenia Gravis, Tocilizumab, Open-label
Eligibility 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; 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.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical University
- Xiangya Hospital Central South University
- Tangdu Hospital, The Fourth Military Medical University
- Huashan Hospital
- West China Hospital of Sichuan University
- Tianjin medical university general hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tocilizumab
Arm Description
Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events (TEAEs)
Secondary Outcome Measures
Change in Quantitative Myasthenia Gravis (QMG) scores.
Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks
Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score
Change in Myasthenia Gravis Composite (MGC) score
Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05716035
Brief Title
Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis
Acronym
tMG-E
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis, Generalized
Keywords
Generalized Myasthenia Gravis, Tocilizumab, Open-label
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tocilizumab
Arm Type
Experimental
Arm Description
Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab Injection
Intervention Description
Participants will receive IV tocilizumab
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)
Secondary Outcome Measure Information:
Title
Change in Quantitative Myasthenia Gravis (QMG) scores.
Time Frame
16 weeks
Title
Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks
Time Frame
16 weeks
Title
Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks
Time Frame
16 weeks
Title
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score
Time Frame
16 weeks
Title
Change in Myasthenia Gravis Composite (MGC) score
Time Frame
16 weeks
Title
Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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;
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.
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Tangdu Hospital, The Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin medical university general hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis
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