Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

Sponsor
Marmara University
Study ID
NCT07491913
Status
Recruiting
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Conditions

  • Takayasu Arteritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tociliuzumab — DRUG
    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.
  • Infliximab — DRUG
    Dose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
  • Adalimumab — DRUG
    Dose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
  • Certolizumab Pegol — DRUG
    Dose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.

Study Details

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.

Key Dates

Start date
Jun 15, 2025
Status verified
Mar 2026
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Biologic Treatment Withdrawal
    Patients with Takayasu arteritis in sustained clinical and radiologic remission who have received biologic therapy for at least 3 years will undergo a predefined 3-month biologic dose tapering protocol followed by complete treatment discontinuation and a 12-month follow-up period to evaluate remission maintenance and relapse rates.

Primary Outcome Measure

Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal [ Time Frame: 12 months after treatment discontinuation ]

Central Contacts

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