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A Pilot Study in Severe Patients With Takayasu Arteritis.
Sponsor: Shanghai Zhongshan Hospital
Summary
Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild, moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly prescribed in severe patients, to find out the relatively better treatment strategy, facilitating better intervention strategy in severe TAK patients.
Official title: A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort
Key Details
Gender
All
Age Range
14 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2020-03-01
Completion Date
2023-12-31
Last Updated
2021-08-10
Healthy Volunteers
No
Interventions
Tocilizumab
The tocilizumab group is prescribed with tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of tocilizumab is maintained for another 24 weeks, otherwise (resistant), patients would be given adalimumab (40mg.bim.IH.) for 24 weeks instead.
Adalimumab
The adalimumab group is prescribed with adalimumab (40mg.bim.IH) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of adalimumab would be maintained for another 24 weeks, otherwise (resistant), patients would be given tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks instead.
Locations (1)
Department of Rheumatology in Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China