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
Study ID
NCT06498089
Phase
PHASE4
Status
Recruiting
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Conditions

  • Takayasu Arteritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    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 — DRUG
    This drug will be used in the traditional arm. A dose of 15mg per week will be used.
  • Tocilizumab — DRUG
    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 — DRUG
    This drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day).
  • Adalimumab — DRUG
    This drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks.

Study Details

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 Dates

Start date
Jun 28, 2024
Status verified
Oct 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: The precise therapy arm
    Patients will be given treatment based on their clinical-molecular phenotype according to a predesigned scheme: 1. Patients in constitutional type will be given treatments with GCs combined with TCZ and MTX. 2. Patients in vascular inflammation type without IL-6 and TNF-α elevation will be given treatments with GCs combined with TOF. 3. Patients in vascular inflammation type with IL-6 elevation will be given treatments with GCs combined with TCZ and MTX. 4. Patients in vascular inflammation type with TNF-α elevation will be given treatments with GCs combined with ADA and MTX.
  • Active Comparator: The traditional therapy arm
    Patients will be given traditional treatment based on their clinical-molecular phenotype according to a predesigned scheme.

Primary Outcome Measure

Effectiveness rate [ Time Frame: 6 months ]

Central Contacts

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