Actively Recruiting
Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission
Led by Marmara University · Updated on 2026-03-25
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Takayasu arteritis is a chronic inflammation of large blood vessels, mainly affecting the aorta and its main branches. This research focuses on evaluating the outcomes of stopping biologic treatments in patients who have maintained long-term remission using these therapies. The study aims to understand how safe it is to discontinue biologic drugs like tumor necrosis factor inhibitors and tocilizumab after at least three years of use in patients with stable disease. Participants will undergo a specific 3-month dose tapering of their biologic medication. If they do not experience a relapse during this tapering phase, they will completely stop the biologic treatment. After stopping, patients will be followed for 12 months to monitor their health. Clinical and laboratory assessments will be done one month after stopping treatment and then every three months. Imaging tests will be done as needed based on clinical evaluations. Throughout the study, researchers will measure how many patients maintain remission 12 months after stopping biologic therapy. They will also track the rate and timing of disease relapse during both the tapering and follow-up periods. Additional analyses will explore factors that might predict relapse and differences related to the type of biologic agent used or other treatments. The total participation includes the tapering period plus a year of follow-up to closely observe patient outcomes.
CONDITIONS
Brief Title
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Takayasu arteritis according to 2022 American College of Rheumatology/EULAR criteria
- Treated with biologic therapy (TNF inhibitors or tocilizumab) for at least 3 years
- In sustained clinical, laboratory, and radiologic remission
- No changes in treatment during the previous 12 months
- No glucocorticoid use within the previous 6 months
- Able and willing to provide written informed consent
You will not qualify if you...
- Having other active inflammatory diseases requiring biologic therapy (e.g., inflammatory bowel disease, ankylosing spondylitis)
- Unable to attend scheduled follow-up visits after tapering and discontinuation
- Pregnant or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants undergo a predefined 3-month biologic dose tapering protocol to gradually reduce their biologic therapy.
Visits as needed during tapering period
Duration - 12 months
After completing the tapering phase, participants discontinue biologic therapy completely and are followed for 12 months to monitor remission maintenance and detect any relapses.
Visits at 1 month after discontinuation and every 3 months thereafter
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
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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