Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis (tMG-E)

January 18, 2024 updated by: changting, Tang-Du Hospital

A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Not yet recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Shaanxi
    • Shanghai
      • Shanghai, Shanghai, China, 200040
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)
From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Quantitative Myasthenia Gravis (QMG) scores.
Time Frame: 16 weeks
16 weeks
Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks
Time Frame: 16 weeks
16 weeks
Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks
Time Frame: 16 weeks
16 weeks
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score
Time Frame: 16 weeks
16 weeks
Change in Myasthenia Gravis Composite (MGC) score
Time Frame: 16 weeks
16 weeks
Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1.0, 20221201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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