Using Tocilizumab to treat Generalized Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Tocilizumab in patients diagnosed with Generalized Myasthenia Gravis who are positive for anti-AChR antibodies. Approximately 64 subjects will be enrolled across six study sites, with eligibility based on specific clinical classifications and scores. The study includes a randomized controlled period followed by an optional one-year open-label extension for participants who complete the initial phase.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tangdu Hospital, The Fourth Military Medical University
  Xi'an, Shaanxi, China Recruiting
• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Xiangya Hospital Central South University
  Changsha, Hunan, China Not yet recruiting
• Huashan Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Not yet recruiting
• Tianjin medical university general hospital
  Tianjin, Tianjin Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Ting Chang, MD,PHD
• Email: changting1981@163.com
• Phone: +86-29-84778845

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Claseprubart in adults with generalized myasthenia gravis

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• Aritinercept for generalized myasthenia gravis

  This study tests whether aritinercept is safe and helpful for adults with generalized myasthenia gravis compared with placebo.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.