Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis

NCT ID: NCT05716035

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-12-31

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.

Conditions

Myasthenia Gravis, Generalized

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tocilizumab

Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.

Group Type: EXPERIMENTAL

Tocilizumab Injection

Intervention Type: DRUG

Participants will receive IV tocilizumab

Interventions

Tocilizumab Injection

Participants will receive IV tocilizumab

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

changting

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status: NOT_YET_RECRUITING

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: NOT_YET_RECRUITING

Tianjin medical university general hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Fudong Shi, MD,PHD

Role: primary

fshi@tmu.edu.cn

+86-22-60817429

Huan Yang, MD,PHD

Role: primary

yxyx69@gahoo.com.cn

Ting Chang

Role: primary

changting1981@163.com

02984778845

Zhe Ruan

Role: backup

ruanzhe573291596@126.com

Chongbo Zhao, MD,PHD

Role: primary

zhao_chongbo@fudan.edu.cn

86-21-52889999

Hongyu Zhou, MD,PHD

Role: primary

zhouhy@scu.edu.cn

Chao Zhang, MD,PHD

Role: primary

chaozhang@tmu.edu.cn

+86-22-60362255

Other Identifiers

V1.0, 20221201

Identifier Type: -

Identifier Source: org_study_id