Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Sarcopenia
Treatment
Tocilizumab Injectable Product
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thisscore 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 torandomization;
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 torandomization and no dose increase within 4 months prior to randomization.
Exclusion
Exclusion Criteria:
Participants had clinically relevant active infections (such as sepsis, pneumonia,or abscess) or severe infections (resulting in hospitalization or requiringantibiotic treatment) in the 4 weeks before randomization;
Those with a history of high-risk tuberculosis infection, acquired tuberculosisinfection, and chronic hepatitis;
Human immunodeficiency virus (HIV) infection;
Thymomas that have received thymectomy or planned thymectomy during RCP within 6months before randomization, or require chemotherapy and/or radiotherapy at anytime;
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.
Study Design
Study Description
Connect with a study center
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha, Hunan 410008
ChinaSite Not Available
Tangdu Hospital, The Fourth Military Medical University
Xi'an, Shaanxi 710038
ChinaActive - Recruiting
Huashan Hospital
Shanghai, Shanghai 200040
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
Tianjin medical university general hospital
Tianjin, Tianjin 300052
ChinaSite Not Available

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