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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

NCT06498089 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-10-17

No results posted yet for this 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.

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Lindi Jiang, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06498089 on ClinicalTrials.gov