๐ฌIn plain words
What the trial is, and whether it could suit you
This study aimed to compare 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 based on a randomized, controlled, open-label, multicenter study.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ2; 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 โฅ4 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 โฅ8 weeks if elimination is not used; for cyclophosphamide, discontinuation is required for โฅ6 months; for biologics, stopping for โฅ 3 weeks is required for etanercept, โฅ 4 weeks for IL-6 receptor antagonists and tumour necrosis factor inhibitors, and โฅ 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 โฅ 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.