RecruitingNot ApplicableNCT07491913

Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission


Sponsor

Marmara University

Enrollment

40 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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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Interventions

DRUGTociliuzumab

Dose tapering of tocilizumab followed by complete treatment discontinuation after a 3-month tapering period in patients with Takayasu arteritis in sustained clinical and radiologic remission.

DRUGInfliximab

Dose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.

DRUGAdalimumab

Dose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.

DRUGCertolizumab Pegol

Dose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.


Locations(1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

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NCT07491913


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