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Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
Sponsor: Marmara University
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.
Official title: Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-06-15
Completion Date
2027-12-15
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Tociliuzumab
Dose tapering of tocilizumab followed by complete treatment discontinuation after a 3-month tapering period in patients with Takayasu arteritis in sustained clinical and radiologic remission.
Infliximab
Dose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
Adalimumab
Dose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
Certolizumab Pegol
Dose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
Locations (1)
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)