Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Myasthenia Gravis, Generalized
In brief
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Key facts
- Study ID
- NCT05067348
- Run by
- Tang-Du Hospital
- People needed
- 64
- Starts
- 2022-07-21
- Expected to finish
- 2026-03-30
- Last updated by the study team
- 2025-05-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Tangdu Hospital, The Fourth Military Medical University — Xi'an, Shaanxi, China (enrolling)
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China
- Xiangya Hospital Central South University — Changsha, Hunan, China
- Huashan Hospital — Shanghai, Shanghai Municipality, China
- West China Hospital of Sichuan University — Chengdu, Sichuan, China
- Tianjin medical university general hospital — Tianjin, Tianjin Municipality, China
Full record on ClinicalTrials.gov
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