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Tests treatment safety and results for Myasthenia Gravis, Generalized
Official title Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT05067348
What this study is testing
What is Tocilizumab Injectable Product?
Tocilizumab Injectable Product is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myasthenia gravis, generalized.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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.
- people must be on:
You likely can't join if
- Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or...
- 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...
- Received rituximab treatment in the past 6 months before randomization;
- Received tocilizumab or eculizumab treatment within 3 months before randomization;
See the full eligibility 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 this score attributed to non-ocular items.
- QMG score of 11 or greater.
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Changsha, Hunan, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Changsha, Hunan, China; Xi'an, Shaanxi, China; Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.