Tests tocilizumab for generalized myasthenia gravis, a muscle weakness disease
Tests tocilizumab against a placebo in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Key facts
- Where
- Beijing, Changsha, Chengdu, Shanghai, Tianjin, and Xi’an, ChinaSee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05067348, who can take part
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaNot yet recruiting
- Xiangya Hospital Central South UniversityChangsha, ChinaNot yet recruiting
- West China Hospital of Sichuan UniversityChengdu, ChinaNot yet recruiting
- Huashan HospitalShanghai, ChinaNot yet recruiting
- Tianjin Medical University General HospitalTianjin, ChinaNot yet recruiting
- Tangdu Hospital, The Fourth Military Medical UniversityXi’an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tang-Du Hospital
- Trial code
- NCT05067348
- Record updated
- 1 May 2025
- Original description
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.Read full original descriptionShow less
A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Inclusion: 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: 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; 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; Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis; Human immunodeficiency virus (HIV) infection; History of other tumor diseases; Unresected thymoma.