RecruitingPhase 4NCT06498089

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

124 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Adalimumab, a drug called Methotrexate, and others for people with takayasu arteritis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrednisone

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.

DRUGMethotrexate

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

DRUGTocilizumab

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).

DRUGTofacitinib

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

DRUGAdalimumab

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


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06498089


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