RecruitingNot Applicable

Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

Turkey (Türkiye)40 participantsStarted 2025-06-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal

Timeframe: 12 months after treatment discontinuation

Trial details

NCT IDNCT07491913

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-15

Contact for this trial

Fatma Alibaz-Oner, MD

05326368554 falibaz@gmail.com

View on ClinicalTrials.gov More Takayasu Arteritis trials