NCT05716035

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 27, 2023

Last Update Submit

January 18, 2024

Conditions

Myasthenia Gravis, Generalized

Keywords

Generalized Myasthenia GravisTocilizumabOpen-label

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAEs)

    From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)

Secondary Outcomes (6)

  • Change in Quantitative Myasthenia Gravis (QMG) scores.

    16 weeks

  • Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks

    16 weeks

  • Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks

    16 weeks

  • Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score

    16 weeks

  • Change in Myasthenia Gravis Composite (MGC) score

    16 weeks

  • +1 more secondary outcomes

Study Arms (1)

tocilizumab

EXPERIMENTAL

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

Drug: Tocilizumab Injection

Interventions

Tocilizumab InjectionDRUG

Participants will receive IV tocilizumab

tocilizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

NOT YET RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

NOT YET RECRUITING

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin medical university general hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 8, 2023

Study Start

April 1, 2023

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)