Stopping biologic therapy in Takayasu arteritis patients in long-term remission
Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission
This study will try stopping biologic medicines (TNF inhibitors or tocilizumab) in people with Takayasu arteritis who have been in clinical and imaging remission for at least three years to see if remission lasts for 12 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Marmara University Academic / other |
| Drugs / interventions | tocilizumab |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07491913 on ClinicalTrials.gov |
What this trial studies
Eligible patients with Takayasu arteritis who have received a biologic for at least three years and are in sustained clinical, laboratory, and radiologic remission will undergo a predefined 3-month dose tapering protocol. Patients who remain relapse-free during the taper will discontinue biologic therapy and be followed for 12 months with clinical and laboratory visits at 1 month and then every 3 months, with imaging as clinically indicated. The primary outcome is the proportion of participants who maintain remission at 12 months after stopping biologic therapy. The protocol includes commonly used agents such as infliximab, adalimumab, certolizumab pegol, and tocilizumab.
Who should consider this trial
Good fit: Ideal candidates are adults with Takayasu arteritis treated with a TNF inhibitor or tocilizumab for at least three years who have sustained clinical, laboratory, and radiologic remission and no glucocorticoid use in the prior six months.
Not a fit: Patients with recent disease activity, other active inflammatory diseases requiring biologics, inability to attend follow-up visits, or who are pregnant or planning pregnancy are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this approach could allow some patients to stop long-term biologic treatment, reducing medication side effects, infection risk, and cost.
How similar studies have performed: Limited retrospective and observational data suggest some patients with large-vessel vasculitis can remain in remission after stopping biologics, but prospective evidence in Takayasu arteritis is sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul
- Marmara University Pendik Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Fatma Alibaz-Oner, MD — Marmara University
- Study coordinator: Fatma Alibaz-Oner, MD
- Email: falibaz@gmail.com
- Phone: 05326368554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.