Comparing Precision and Conventional Treatments for Active Takayasus Arteritis in Adults 18-65 Years A Randomized, Controlled, Open-Label Multicenter Study

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a precision treatment plan tailored to clinical-molecular phenotypes compared with a conventional treatment approach in adults with active Takayasus arteritis. This randomized, controlled, open-label, multicenter study aims to provide clearer insights into managing this condition by assessing outcomes over a 14-month period, including a 6-month induction remission phase and an 8-month maintenance phase. Participants will be randomly assigned to either the precision therapy group or the conventional therapy group. The precision group receives treatments based on their clinical-molecular phenotype constitutional type patients get glucocorticoids combined with tocilizumab and methotrexate vascular inflammation type patients receive combinations involving glucocorticoids plus tofacitinib, tocilizumab, adalimumab, and methotrexate depending on specific cytokine elevations. The conventional group receives traditional treatments based on clinical-molecular phenotypes. Prednisone dosing starts based on weight and is gradually tapered over the study. During the study, participants undergo evaluations including effectiveness rates at 6 and 12 months, relapse rates, safety monitoring, hormone dosage tracking, vascular imaging, and cytokine profile changes. Patient-reported outcomes like pain scores, quality of life surveys, and fatigue assessments are also collected. The study includes monitoring for adverse events and continues follow-up through the full 14-month period to assess long-term treatment effects and disease control.

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