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Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis (tMG)

Primary Purpose

Myasthenia Gravis, Generalized

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tocilizumab Injectable Product
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis, Generalized focused on measuring Generalized Myasthenia Gravis, Tocilizumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of MG with anti-AChRantibody.
  2. MGFA Clinical Classification Class II, III, or IV.
  3. MG-ADL score of 5 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
  4. QMG score of 11 or greater.

  5. Subjects must be on:

    1. Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;
    2. Corticosteroids, with no dose increase within 4 weeks prior to randomization; or/and c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.

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 4 weeks before randomization;
  2. Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;
  3. Human immunodeficiency virus (HIV) infection;
  4. Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time;
  5. Received rituximab treatment in the past 6 months before randomization;
  6. Received tocilizumab or eculizumab treatment within 3 months before randomization;
  7. Received IVIG or plasma exchange within 4 weeks before randomization;
  8. Unresected thymoma.
  9. History of other tumor diseases.

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical University
  • Xiangya Hospital Central South University
  • Tangdu Hospital, The Fourth Military Medical UniversityRecruiting
  • Huashan Hospital
  • West China Hospital of Sichuan University
  • Tianjin medical university general hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tocilizumab

Placebo

Arm Description

Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.

Participants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.

Outcomes

Primary Outcome Measures

Change in Quantitative Myasthenia Gravis (QMG) scores.

Secondary Outcome Measures

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 (MGQOL-15r) score.
Change in Myasthenia Gravis Impairment Index (MGII) score.
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the randomized controlled period and open-label period.

Full Information

First Posted
September 23, 2021
Last Updated
September 15, 2022
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05067348
Brief Title
Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Acronym
tMG
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Detailed Description
This study is a randomized, double-blind, placebo-controlled study, to be conducted at 6 study sites. Approximately 64 subjects will be enrolled. Patients with MG who are positive for anti-AChR antibodies will be enrolled. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score ≥ 5, QMG score ≥ 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study. All subjects who complete the randomized controlled period will have the option to enroll in a 1-year open-label period.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab
Arm Type
Experimental
Arm Description
Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab Injectable Product
Intervention Description
Participants will receive IV tocilizumab
Primary Outcome Measure Information:
Title
Change in Quantitative Myasthenia Gravis (QMG) scores.
Time Frame
16 weeks
Secondary Outcome Measure Information:
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 (MGQOL-15r) score.
Time Frame
16 weeks
Title
Change in Myasthenia Gravis Impairment Index (MGII) score.
Time Frame
16 weeks
Title
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the randomized controlled period and open-label period.
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: Diagnosis of MG with anti-AChRantibody. MGFA Clinical Classification Class II, III, or IV. MG-ADL score of 5 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items. QMG score of 11 or greater. Subjects must be on: Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization; Corticosteroids, with no dose increase within 4 weeks prior to randomization; or/and c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization. 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 4 weeks before randomization; Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis; Human immunodeficiency virus (HIV) infection; Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time; Received rituximab treatment in the past 6 months before randomization; Received tocilizumab or eculizumab treatment within 3 months before randomization; Received IVIG or plasma exchange within 4 weeks before randomization; Unresected thymoma. History of other tumor diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Chang, MD,PHD
Phone
+86-29-84778845
Email
changting1981@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Ruan
Phone
+86-29-84778845
Email
ruanzhe573291596@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Chang, MD,PHD
Organizational Affiliation
The Second Affiliated Hospital of Air Force Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fudong Shi, MD,PHD
Phone
+86-22-60817429
Email
fshi@tmu.edu.cn
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan Yang, MD,PHD
Email
yxyx69@gahoo.com.cn
Facility Name
Tangdu Hospital, The Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Chang
Phone
02984778845
Email
changting1981@163.com
First Name & Middle Initial & Last Name & Degree
Zhe Ruan
Email
ruanzhe573291596@126.com
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chongbo Zhao, MD,PHD
Phone
86-21-52889999
Email
zhao_chongbo@fudan.edu.cn
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhou, MD,PHD
Email
zhouhy@scu.edu.cn
Facility Name
Tianjin medical university general hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Zhang, MD,PHD
Phone
+86-22-60362255

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

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