Tocilizumab Injectable Product: Participants will receive IV tocilizumab
Study summary
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in Quantitative Myasthenia Gravis (QMG) scores. — 16 weeks
Trial sites (6)
Facility
City
Region
Status
Beijing Tiantan Hospital, Capital Medical University
Beijing
Beijing Municipality
Not Yet Recruiting
Xiangya Hospital Central South University
Changsha
Hunan
Not Yet Recruiting
Tangdu Hospital, The Fourth Military Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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