Actively Recruiting
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial of Tocilizumab in Generalized Myasthenia Gravis
Led by Tang-Du Hospital · Updated on 2025-05-01
64
Participants Needed
6
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the effects of tocilizumab in adults with generalized myasthenia gravis (MG) who test positive for anti-AChR antibodies. The study enrolls patients with moderate to severe MG classified as MGFA class II, III, or IV, who have significant symptoms measured by MG-ADL and QMG scores. The trial is designed as a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tocilizumab in this population. Participants are randomly assigned to receive either tocilizumab or a placebo, both given by intravenous infusion at weeks 1, 5, 9, and 13 during the controlled study period. After completing this phase, subjects may join a one-year open-label extension where all participants can receive tocilizumab. The study is conducted across multiple centers and includes approximately 64 participants. Throughout the trial, participants will undergo regular evaluations including muscle strength and daily living activity assessments such as the Quantitative Myasthenia Gravis (QMG) score and MG-ADL profile. Researchers will monitor changes in these scores and quality of life, as well as track any adverse events during both the controlled and open-label periods. The total study duration includes a 16-week controlled period followed by optional extended treatment and observation.
CONDITIONS
Brief Title
Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myasthenia gravis with positive anti-AChR antibody
- MGFA Clinical Classification Class II, III, or IV
- MG-ADL score of 5 or greater at screening and randomization, with more than 50% due to non-ocular symptoms
- QMG score of 11 or greater
- Current use of cholinesterase inhibitor with no dose increase within 4 weeks prior to randomization
- Current use of corticosteroids with no dose increase within 4 weeks prior to randomization
- Use of non-steroidal immunosuppressant for at least 6 months with no dose increase within 4 months prior to randomization
You will not qualify if you...
- Active or severe infections within 4 weeks before randomization
- History of high-risk or acquired tuberculosis infection, or chronic hepatitis
- Human immunodeficiency virus (HIV) infection
- Thymomas with recent or planned thymectomy within 6 months or requiring chemotherapy/radiotherapy
- Rituximab treatment within 6 months before randomization
- Tocilizumab or eculizumab treatment within 3 months before randomization
- Intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks before randomization
- Unresected thymoma
- History of other tumor diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive intravenous infusions of tocilizumab or placebo on weeks 1, 5, 9, and 13 during the randomized controlled period.
4 infusion visits
Duration - 1 year
Participants who complete the randomized controlled period have the option to enroll in a 1-year open-label period receiving tocilizumab.
Visit schedule varies during open-label period
Trial Site Locations
Total: 6 locations
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
2
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
3
Tangdu Hospital, The Fourth Military Medical University
Xi'an, Shaanxi, China, 710038
Actively Recruiting
4
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Not Yet Recruiting
5
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
6
Tianjin medical university general hospital
Tianjin, Tianjin Municipality, China, 300052
Not Yet Recruiting
Research Team
T
Ting Chang, MD,PHD
Z
Zhe Ruan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here