Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

NCT07491913 · tracked via the Priya Life Science Turkey tracker

Sponsor

Marmara University

Phase

Not applicable

Started

2025-06-15

Last updated

2026-03-25

Condition(s) studied

Takayasu Arteritis

Investigational drug(s) / intervention(s)

TociliuzumabInfliximab →Adalimumab →Certolizumab Pegol →

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

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

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal — 12 months after treatment discontinuation
The proportion of patients with Takayasu arteritis who maintain clinical and laboratory remission without relapse following biologic treatment withdrawal after a predefined tapering protocol.

Trial sites (1)

Facility	City	Region	Status
Marmara University Pendik Training and Research Hospital	Istanbul	Turkey (Türkiye)	Recruiting

On this site

📄 Remicade (infliximab) drug profile → 📄 Humira (adalimumab) drug profile → 📄 Cimzia (certolizumab pegol) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07491913 on ClinicalTrials.gov ↗ ← All trials in Turkey