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Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

RecruitingNAAges 18 Years - anyAllMarmara University
NCT07491913 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Tociliuzumab
  • Infliximab
  • Adalimumab
  • Certolizumab Pegol
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Where

1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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