Trial Title:
Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis
NCT ID:
NCT05716035
Condition:
Myasthenia Gravis, Generalized
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Generalized Myasthenia Gravis
Tocilizumab
Open-label
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tocilizumab Injection
Description:
Participants will receive IV tocilizumab
Arm group label:
tocilizumab
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fudong Shi, MD,PHD
Phone:
+86-22-60817429
Email:
fshi@tmu.edu.cn
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Huan Yang, MD,PHD
Email:
yxyx69@gahoo.com.cn
Facility:
Name:
Tangdu Hospital, The Fourth Military Medical University
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Chang
Phone:
02984778845
Email:
changting1981@163.com
Contact backup:
Last name:
Zhe Ruan
Email:
ruanzhe573291596@126.com
Facility:
Name:
Huashan Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Chongbo Zhao, MD,PHD
Phone:
86-21-52889999
Email:
zhao_chongbo@fudan.edu.cn
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongyu Zhou, MD,PHD
Email:
zhouhy@scu.edu.cn
Facility:
Name:
Tianjin medical university general hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Status:
Recruiting
Contact:
Last name:
Chao Zhang, MD,PHD
Phone:
+86-22-60362255
Email:
chaozhang@tmu.edu.cn
Start date:
April 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Tang-Du Hospital
Agency class:
Other
Source:
Tang-Du Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05716035
