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โ† Trials
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Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

RecruitingPhase 2Ages 18 Years - 80 YearsAllTang-Du Hospital
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In plain words

What the trial is, and whether it could suit you

Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Tocilizumab Injectable Product
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Where

6 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Xiangya Hospital Central South University
Changsha, China
Tangdu Hospital, The Fourth Military Medical University
Xi'an, China
Huashan Hospital
Shanghai, China
West China Hospital of Sichuan University
Chengdu, China
Tianjin medical university general hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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