Takayasu ArteritisNCT07491913
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission
A study testing Tociliuzumab, Infliximab and Adalimumab in people with Takayasu Arteritis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takayasu Arteritis
- What is being tested?
- Tociliuzumab, Infliximab and Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul
Fatma Alibaz-Oner, MD, falibaz@gmail.com
About this study
Official title: Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission
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.
Read the detailed description
Takayasu arteritis (TAK) is a chronic granulomatous large-vessel vasculitis that primarily affects the aorta and its major branches. Despite advances in treatment, many patients require long-term immunosuppressive therapy to maintain disease control. Biologic agents, particularly tumor necrosis factor inhibitors and interleukin-6 receptor inhibitors such as tocilizumab, have demonstrated efficacy in 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 interventional study is designed to evaluate the outcomes of planned biologic treatment withdrawal in patients with Takayasu arteritis who have achieved long-standing clinical and radiologic remission and have received biologic therapy for at least three years. Eligible patients will undergo a predefined dose tapering protocol over a 3-month period. Patients who do not experience relapse during this phase will discontinue biologic therapy completely at the end of the tapering period.
Following treatment discontinuation, patients will be followed for 12 months. Clinical and laboratory evaluations will be performed at 1 month after discontinuation and every 3 months thereafter. Imaging studies will be performed as clinically indicated.
The primary outcome of the study is the proportion of patients maintaining remission at 12 months after biologic treatment withdrawal. Secondary outcomes include the rate and timing of major and minor relapses during the tapering phase and the post-withdrawal follow-up period. Additional analyses will explore potential predictors of relapse and differences according to biologic agent type and concomitant therapies.
- Conditions
- Takayasu Arteritis
- Being tested
- Tociliuzumab, Infliximab, Adalimumab, Certolizumab Pegol
- Keywords
- Takayasu arteritis, Biologic therapy withdrawal, Treatment discontinuation, TNF inhibitors, Tocilizumab, Large vessel vasculitis
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TociliuzumabDrug
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.
InfliximabDrug
Dose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
AdalimumabDrug
Dose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
Certolizumab PegolDrug
Dose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tociliuzumab; Drug: Infliximab; Drug: Adalimumab; Drug: Certolizumab Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after treatment discontinuation
Secondary outcomes (2)
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.
Measured: Up to 15 months
Time to Disease Relapse
Time from biologic treatment discontinuation to the occurrence of the first major or minor relapse in patients with Takayasu arteritis.
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Jun 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Alibaz Oner, Marmara University
- Investigators
- Fatma Alibaz-Oner, MD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491913
- Sponsor's protocol ID
- 09.2024.1469
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon reasonable request and subject to approval by the principal investigator and the ethics committee, in accordance with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission
- ClinicalTrials.gov ID
- NCT07491913
- Acronym / sponsor ID
- 09.2024.1469
- Conditions
- Takayasu Arteritis
- Keywords
- Takayasu arteritis, Biologic therapy withdrawal, Treatment discontinuation, TNF inhibitors, Tocilizumab, Large vessel vasculitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Takayasu arteritis (TAK) is a chronic granulomatous large-vessel vasculitis that primarily affects the aorta and its major branches. Despite advances in treatment, many patients require long-term immunosuppressive therapy to maintain disease control. Biologic agents, particularly tumor necrosis factor inhibitors and interleukin-6 receptor inhibitors such as tocilizumab, have demonstrated efficacy in 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 interventional study is designed to evaluate the outcomes of planned biologic treatment withdrawal in patients with Takayasu arteritis who have achieved long-standing clinical and radiologic remission and have received biologic therapy for at least three years. Eligible patients will undergo a predefined dose tapering protocol over a 3-month period. Patients who do not experience relapse during this phase will discontinue biologic therapy completely at the end of the tapering period.
Following treatment discontinuation, patients will be followed for 12 months. Clinical and laboratory evaluations will be performed at 1 month after discontinuation and every 3 months thereafter. Imaging studies will be performed as clinically indicated.
The primary outcome of the study is the proportion of patients maintaining remission at 12 months after biologic treatment withdrawal. Secondary outcomes include the rate and timing of major and minor relapses during the tapering phase and the post-withdrawal follow-up period. Additional analyses will explore potential predictors of relapse and differences according to biologic agent type and concomitant therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Biologic Treatment Withdrawal | Experimental | Drug: Tociliuzumab, Drug: Infliximab, Drug: Adalimumab, Drug: Certolizumab PegolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TociliuzumabDose 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. | Drug | Biologic Treatment Withdrawal |
| InfliximabDose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission. | Drug | Biologic Treatment Withdrawal |
| AdalimumabDose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission. | Drug | Biologic Treatment Withdrawal |
| Certolizumab PegolDose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission. | Drug | Biologic Treatment Withdrawal |
Primary outcome
Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal
Time frame: 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.
2 secondary outcomes
Rate of Disease Relapse
Time frame: Up to 15 months
Time to Disease Relapse
Time frame: Up to 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon reasonable request and subject to approval by the principal investigator and the ethics committee, in accordance with institutional and ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma Alibaz-Oner, MD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tociliuzumab, Infliximab and Adalimumab in people with Takayasu Arteritis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Alibaz-Oner, MD (05326368554, falibaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal (time frame: 12 months after treatment discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.