Pilot Study Comparing Tocilizumab and Adalimumab Treatments in Severe Takayasu Arteritis Patients

What this Trial Is About

Takayasu arteritis TAK is a rare chronic inflammatory disease affecting arteries, and there is no widely accepted effective treatment strategy. Researchers classify TAK patients into three severity levels mild, moderate, and severe. This study focuses on severe TAK patients and compares two biological agents, tocilizumab and adalimumab, to find which treatment may provide better intervention outcomes in this group. The study randomly assigns severe TAK patients to receive either tocilizumab at a dose of 8mgkg intravenously every four weeks or adalimumab at 40mg biweekly by injection for 24 weeks. Patients start with prednisone at 40mg daily, tapered gradually over months, and treatment adjustments are made if disease relapse occurs. After 24 weeks, if remission is not achieved, patients switch to the other biological agent for an additional 24 weeks. Participants are monitored throughout treatment and follow-up for disease remission using clinical and laboratory assessments. Researchers track disease relapse, vascular progression through angiographic exams, prednisone dose reduction, and quality of life changes using questionnaires over a total of 48 weeks. The primary outcome is disease remission at 24 weeks. Safety and disease activity are closely observed during the study.

A Pilot Study in Severe Patients With Takayasu Arteritis.