Long-term treatment with tocilizumab for generalized myasthenia gravis
A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)
This study is testing if long-term treatment with tocilizumab can safely help people with generalized myasthenia gravis who have already tried it before.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tang-Du Hospital Academic / other |
| Drugs / interventions | tocilizumab |
| Locations | 6 sites (Beijing, Beijing and 5 other locations) |
| Trial ID | NCT05716035 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety and efficacy of tocilizumab in patients with generalized myasthenia gravis who previously participated in a related study. Participants who completed the initial study will receive open-label tocilizumab injections for up to 16 weeks. The goal is to gather clinical data that will inform the ongoing assessment of tocilizumab's effects on this condition. The study aims to provide insights into the treatment's long-term benefits and risks.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed the initial study and have a specific score indicating the severity of their myasthenia gravis.
Not a fit: Patients with recent severe infections or those who have undergone certain treatments like IVIG or plasma exchange may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of generalized myasthenia gravis, enhancing patients' quality of life.
How similar studies have performed: Previous studies involving tocilizumab have shown promise, suggesting that this approach may be effective for treating generalized myasthenia gravis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant has completed Study tMG. 2. Participant has given written informed consent. 3. MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study 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 past 4 weeks; 2. Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study; 3. planned thymectomy during RCP; 4. Received IVIG or plasma exchange in the past 4 weeks; 5. Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.
Where this trial is running
Beijing, Beijing and 5 other locations
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing, China (Not_yet_recruiting)
- Xiangya Hospital Central South University — Changsha, Hunan, China (Not_yet_recruiting)
- Tangdu Hospital, The Fourth Military Medical University — Xi'an, Shaanxi, China (Recruiting)
- Huashan Hospital — Shanghai, Shanghai, China (Recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
- Tianjin medical university general hospital — Tianjin, Tianjin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.