Actively Recruiting
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
Led by Marmara University · Updated on 2026-03-25
40
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- No glucocorticoid use within the previous 6 months
- Ability and willingness to provide written informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
F
Fatma Alibaz-Oner, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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