Stopping biologic therapy in Takayasu arteritis patients in long-term remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Eligible patients with Takayasu arteritis who have received a biologic for at least three years and are in sustained clinical, laboratory, and radiologic remission will undergo a predefined 3-month dose tapering protocol. Patients who remain relapse-free during the taper will discontinue biologic therapy and be followed for 12 months with clinical and laboratory visits at 1 month and then every 3 months, with imaging as clinically indicated. The primary outcome is the proportion of participants who maintain remission at 12 months after stopping biologic therapy. The protocol includes commonly used agents such as infliximab, adalimumab, certolizumab pegol, and tocilizumab.

Why it matters

Who can join: the full rules

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

Where it's running

• Marmara University Pendik Training and Research Hospital
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Fatma Alibaz-Oner, MD — Marmara University
• Study coordinator: Fatma Alibaz-Oner, MD
• Email: falibaz@gmail.com
• Phone: 05326368554

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.