A Randomized, Controlled, Multicenter Study To Evaluate the Safety and Efficacy of Tocilizumab In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Participants who are aged ≥12 years at the time of signing Informed Consent Form
• Confirmed diagnosis of MOGAD with a history of ≥1 MOGAD relapse in the 12 months prior to screening or ≥2 attacks in the 24 months prior to screening
• Anti-MOG antibody seropositive
• For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of tocilizumab
• Patients must give written informed consent
Locations
Other Locations
China
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Contact Information
Primary
Chao Zhang, M.D., Ph.D
chaozhang@tmu.edu.cn
: +8602260814587
Backup
Yi Shen, M.D., Ph.D
shenyi@tmu.edu.cn
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 102
Treatments
Experimental: Tocilizumab with oral prednisone
Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone
Experimental: Prednisone
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University General Hospital