About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of Takayasu arteritis according to the 2022 American College of Rheumatology/EULAR classification criteria
Treatment with biologic therapy (TNF inhibitors or tocilizumab) for at least 3 years
Sustained clinical, laboratory, and radiologic remission
No change in treatment during the previous 12 months
Disqualifiers
Presence of other active inflammatory diseases requiring biologic therapy (e.g., inflammatory bowel disease, ankylosing spondylitis)
Inability to attend scheduled follow-up visits after treatment tapering and discontinuation
Pregnancy or planning pregnancy during the study period
Trial design
Treatments tested in this trial
- Tociliuzumab
- Infliximab
- Adalimumab
- Certolizumab Pegol