Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

NCT07491913 | Recruiting

• 1 other identifier: 09.2024.1469
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Takayasu Arteritis

Keywords

Takayasu arteritis; Biologic therapy withdrawal; Treatment discontinuation; TNF inhibitors; Tocilizumab; Large vessel vasculitis

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal

  The proportion of patients with Takayasu arteritis who maintain clinical and laboratory remission without relapse following biologic treatment withdrawal after a predefined tapering protocol.

  12 months after treatment discontinuation

Secondary Outcomes (2)

• Rate of Disease Relapse

  Up to 15 months

• Time to Disease Relapse

  Up to 15 months

Study Arms (1)

Biologic Treatment Withdrawal

EXPERIMENTAL

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.

Drug: Tociliuzumab; Drug: Infliximab; Drug: Adalimumab; Drug: Certolizumab Pegol

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.

Biologic Treatment Withdrawal

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.

Biologic Treatment Withdrawal

Adalimumab DRUG

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

Biologic Treatment Withdrawal

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.

Biologic Treatment Withdrawal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

tocilizumab; Infliximab; Adalimumab; Certolizumab Pegol

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides

Study Officials

• Fatma Alibaz-Oner, MD

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Alibaz-Oner, MD

CONTACT

05326368554; falibaz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Model Details: Single-arm interventional study evaluating outcomes after biologic treatment tapering and withdrawal in patients with Takayasu arteritis in sustained remission. Eligible patients will undergo a 3-month dose tapering protocol followed by complete discontinuation of biologic therapy and 12-month follow-up.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication of the study results and will be accessible for 5 years.
• Access Criteria: Data will be available upon reasonable request to the principal investigator. Requests will be evaluated based on scientific merit, and data will be shared in anonymized form in accordance with institutional and ethical guidelines.

Locations

TU (1)