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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Marmara University Pendik Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Fatma Alibaz-Oner, MD
falibaz@gmail.com
05326368554
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Marmara University

This content was sourced from clinicaltrials.gov