A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jul 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for patients with a condition called Takayasu's arteritis, which causes inflammation of large blood vessels. Researchers want to see if a new, personalized treatment plan based on each patient's specific clinical and molecular characteristics is more effective and safer compared to a standard treatment plan. The trial is currently looking for participants aged 18 to 65 who have been diagnosed with active Takayasu's arteritis and meet specific medical criteria.

If you or a loved one qualify for this study, you can expect to receive either the precision treatment or the conventional treatment while being closely monitored by medical professionals. Participants should not have other serious health conditions or infections and should not be taking certain medications before joining the trial. This research aims to improve treatment options for Takayasu's arteritis and might help many patients in the future.

Gender

ALL

Eligibility criteria

• 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.