Comparing precision treatment to conventional treatment for Takayasu's arteritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a precision treatment regimen tailored to clinical-molecular phenotypes against a conventional treatment regimen for patients with active Takayasu's arteritis. Participants will be randomly assigned to either the precision therapy group or the conventional therapy group, with the study spanning 14 months, including a 6-month induction period followed by an 8-month maintenance period. The primary objective is to assess the efficacy of both treatment approaches after six months, while secondary objectives include evaluating relapse rates, safety, and changes in cytokine profiles. The trial will involve patients who meet specific criteria related to their condition and treatment history.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\) Meet the 2022 ACR/EULAR classification criteria for aortitis; 2) Women or men aged 18-65 years; 4) Be in active disease: a National Institutes of Health (NIH) score of ≥2; 5) Females with negative serum or urine pregnancy test results and no plans to have children during the clinical trial; (6) If the patient is taking prednisone or its equivalent, the pre-enrolment dose does not exceed 0.6 mg/kg/day and the dose has been stable for at least 4 weeks; 7) If the patient is receiving other medications for aortitis that are inconsistent with the assigned regimen, discontinuation is required for ≥4 weeks for methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, and tacrolimus; for leflunomide, discontinuation is required for 11 days if elimination methods are used (kolexanil or activated charcoal), or ≥8 weeks if elimination is not used; for cyclophosphamide, discontinuation is required for ≥6 months; for biologics, stopping for ≥ 3 weeks is required for etanercept, ≥ 4 weeks for IL-6 receptor antagonists and tumour necrosis factor inhibitors, and ≥ 6 months for rituximab.

8)For patients with no obvious active tuberculosis lesions but elevated T-spot, it is recommended that infectious specialists evaluate them, and preventive anti-tuberculosis therapy should be performed first if necessary. After T-spot declines, researchers will assess the relevant risks before deciding whether they are suitable to participate in this study, and continue preventive anti-tuberculosis therapy for a total of 9 months.

9)For patients with HBV, if the viral replication was detected, it is recommended to take anti-viral treatment for 2-4 weeks, and researchers will evaluate whether they are suitable to participate in this study when no DNA replication is detected.

Exclusion Criteria:

1. Presence of organ failure;
2. undergoing haemodialysis or major surgery (grade III and above) within 3 months;
3. the presence of other autoimmune diseases;
4. severe, progressive organ damage;
5. Subjects with other comorbidities that may result in the need for additional moderate to high doses of glucocorticoids (prednisone ≥ 10 mg/day or equivalent doses of prednisone equivalents) during the study period;
6. Have a history of malignancy;
7. Have any serious acute or chronic infection, including hepatitis B surface antigen positive, active tuberculosis.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiufang Kong, PhD
• Email: kongxiufang2007@163.com
• Phone: +8618317070593

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Stopping biologic therapy in Takayasu arteritis patients in long-term 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.

  Recruiting Marmara University · Istanbul · NCT07491913

• Understanding patient and physician experiences and attitudes toward care in Takayasu arteritis.

  This project asks adults with Takayasu arteritis and the doctors who treat them to complete online questionnaires to see what their experiences and care priorities are.

  Recruiting University of Edinburgh · Edinburgh · NCT07351422

• Comparing physical and psychosocial health in people with Takayasu arteritis, Behçet's disease, and healthy adults

  This will test whether adults with Takayasu arteritis or Behçet's disease have weaker respiratory and limb muscles, lower exercise capacity, or different quality of life and psychological well‑being compared with healthy adults.

  Recruiting Alanya Alaaddin Keykubat University · Denizli, Denizli · NCT07276087

• Butantan live tetravalent dengue vaccine for people with autoimmune rheumatic diseases

  This study will test whether a single dose of the Butantan live tetravalent dengue vaccine is safe and produces immune responses in clinically stable people aged 12–59 with autoimmune rheumatic diseases compared with matched healthy volunteers.

  Recruiting at 2 sites Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo and 1 other locations · NCT07087912

• Imaging in Inflammatory Heart Diseases linked to autoimmune disorders

  This study tests how well multimodality imaging (CMR, echocardiography, and PET) detects inflammation in people with suspected inflammatory heart or autoimmune rheumatic diseases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07077304

• Blocking endothelin to improve blood vessel function in large vessel vasculitis

  This study is testing if a medication called Bosentan can improve blood vessel function in people with large vessel vasculitis who have been in remission for at least six months.

  Recruiting Phase 2 University of Edinburgh · Edinburgh · NCT06887062

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.