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

PHASE4RecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

June 28, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Takayasu Arteritis
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.

Trial Locations (1)

200032

RECRUITING

Zhongshan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Shanghai Zhongshan Hospital

OTHER