Pilot Study Comparing Tocilizumab and Adalimumab for Treatment of Severe Takayasu Arteritis Based on ECTA Cohort

What this Trial Is About

Researchers are investigating treatment strategies for Takayasu arteritis (TAK), a rare chronic inflammatory disease affecting arteries. This study focuses on severe TAK patients, aiming to compare the effectiveness of two biological agents, tocilizumab and adalimumab, to find the better treatment approach. TAK patients are classified as mild, moderate, or severe based on symptoms and artery involvement, with this study enrolling severe cases characterized by high blood pressure, multiple artery stenoses, and significant organ damage. Participants receive either tocilizumab (8 mg/kg intravenously every week) or adalimumab (40 mg twice monthly by injection) for 24 weeks. After this period, disease remission is assessed. Those who respond continue the same treatment for another 24 weeks. If remission is not achieved, patients switch to the other drug for an additional 24 weeks. All patients also receive a prednisone regimen starting at 40 mg daily, tapered gradually to a maintenance dose, with adjustments made if relapse occurs. Throughout the study, participants undergo regular monitoring of disease activity, including clinical assessments and biomarkers. Researchers evaluate disease remission at 24 weeks as the primary outcome. The study includes careful follow-up to observe treatment effects and safety. Total participation may last up to 48 weeks depending on response and treatment adjustments.

A Pilot Study in Severe Patients With Takayasu Arteritis.