Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarmara University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tociliuzumab
  • Infliximab
  • Adalimumab
  • Certolizumab Pegol

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators