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A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis
Sponsor: Shanghai Zhongshan Hospital
Summary
This study aimed to compare the efficacy and safety of a precision treatment regimen based on clinical-molecular phenotypes with a conventional treatment regimen in the treatment of patients with active Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2024-06-28
Completion Date
2027-06-30
Last Updated
2024-10-17
Healthy Volunteers
No
Conditions
Interventions
Prednisone
This drug will be used in both arms. Patients' initial daily prednisone dose will be calculated according to their weights (0.6mg \* weight(kg), maximum 50mg/day), and then tapered gradually during the study course.
Methotrexate
This drug will be used in the traditional arm. A dose of 15mg per week will be used.
Tocilizumab
This drug will be used in the precise treatment arm. For patients in constitutional type a dose (8mg/kg weight) will be used every 2 weeks (iv drip) for 12 weeks, then a dose (8mg/kg weight) will be used every 4 weeks (iv drip). For patients in vascular inflammation type, a dose (8mg/kg weight) will be used every 4 weeks (iv drip).
Tofacitinib
This drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day).
Adalimumab
This drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks.
Locations (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China