Clinical Trial

Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

Recruiting
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Summary
Takayasu arteritis is a chronic large-vessel vasculitis affecting the aorta and its major branches. Biologic therapies such as tumor necrosis factor inhibitors and tocilizumab are commonly used in patients with refractory or relapsing disease. However, there is limited evidence regarding the optimal duration of biologic therapy and the safety of treatment discontinuation in patients who achieve sustained remission. This prospective study aims to evaluate the outcomes of planned biologic treatment withdrawal in patients with Takayasu arteritis who have been in long-standing clinical and radiologic remission and have received biologic therapy for at least three years. Eligible patients will undergo a predefined 3-month dose tapering protocol. Patients who remain relapse-free during this period will discontinue biologic therapy and will be followed for 12 months. The primary objective of the study is to determine the proportion of patients who maintain remission after biologic treatment withdrawal. Secondary objectives include evaluating the rate and timing of disease relapse during the tapering phase and the post-withdrawal follow-up period.
Trial Details
NCT Number NCT07491913
Lead Sponsor Marmara University
Conditions Takayasu Arteritis
Enrollment 40 participants
Start Date 2025-06-15
Primary Completion 2027-12-15 (estimated)
Study Completion 2027-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-25