Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
ConditionTakayasu Arteritis
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tociliuzumab
DrugDose 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
DrugDose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
Adalimumab
DrugDose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
Certolizumab Pegol
DrugDose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Biologic Treatment WithdrawalExperimental treatment 4 interventions
Trial outcomes
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.
Time frame
12 months after treatment discontinuationSecondary outcomes
1
Rate of Disease Relapse
Proportion of patients experiencing major or minor relapse during the 3-month tapering phase and the 12-month follow-up period after biologic treatment withdrawal.
Time frame
Up to 15 months2
Time to Disease Relapse
Time from biologic treatment discontinuation to the occurrence of the first major or minor relapse in patients with Takayasu arteritis.
Time frame
Up to 15 monthsSponsors and contacts
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Source ClinicalTrials.gov