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Clinical Trials in China / NCT06498089
Recruiting Phase 4

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

NCT06498089 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Phase 4
Started
2024-06-28
Last updated
2024-10-17

Condition(s) studied

Takayasu Arteritis

Investigational drug(s) / intervention(s)

PrednisoneMethotrexateTocilizumabTofacitinibAdalimumab

Prednisone: This drug will be used in both arms. Patients' initial daily prednisone dose will be calculated according to their weights (0.6mg \* weight(kg), maximum 50mg/day), and then tapered gradually during the study course.

Methotrexate: This drug will be used in the traditional arm. A dose of 15mg per week will be used.

Tocilizumab: This drug will be used in the precise treatment arm. For patients in constitutional type a dose (8mg/kg weight) will be used every 2 weeks (iv drip) for 12 weeks, then a dose (8mg/kg weight) will be used every 4 weeks (iv drip). For patients in vascular inflammation type, a dose (8mg/kg weight) will be used every 4 weeks (iv drip).

Tofacitinib: This drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day).

Adalimumab: This drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

On this site

📄 Deltasone (prednisone) drug profile → 📄 Actemra (tocilizumab) drug profile → 📄 Xeljanz (tofacitinib) drug profile → 📄 Humira (adalimumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06498089 on ClinicalTrials.gov ↗ ← All trials in China