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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

RecruitingPhase 4Ages 18 Years - 65 YearsAllShanghai Zhongshan Hospital
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In 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.

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๐Ÿ“‹ 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 โ‰ฅ2; 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 โ‰ฅ4 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 โ‰ฅ8 weeks if elimination is not used; for cyclophosphamide, discontinuation is required for โ‰ฅ6 months; for biologics, stopping for โ‰ฅ 3 weeks is required for etanercept, โ‰ฅ 4 weeks for IL-6 receptor antagonists and tumour necrosis factor inhibitors, and โ‰ฅ 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 โ‰ฅ 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.
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What it tests

  • Prednisone
  • Methotrexate
  • Tocilizumab
  • Tofacitinib
  • Adalimumab
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Where

1 site
Zhongshan Hospital, Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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