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RECRUITING
NCT06498089
PHASE4

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-06-28

Completion Date

2027-06-30

Last Updated

2024-10-17

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Methotrexate

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

DRUG

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).

DRUG

Tofacitinib

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

DRUG

Adalimumab

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