Evaluating treatments for severe Takayasu arteritis

A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort

This study tests whether tocilizumab or adalimumab is more effective for people with severe Takayasu arteritis to help tailor treatments based on their specific needs.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 14 Years to 100 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: tocilizumab, adalimumab, tofacitinib, methotrexate, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04300686 on ClinicalTrials.gov

What this trial studies

This pilot study focuses on patients with severe Takayasu arteritis, a rare chronic inflammatory condition. Patients are classified into three severity levels, and those in the severe category will receive either tocilizumab or adalimumab to determine which treatment is more effective. The study aims to personalize treatment strategies based on individual patient characteristics and disease severity. By comparing the efficacy of these biological agents, the research seeks to improve intervention strategies for severe cases of Takayasu arteritis.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 14 and older with severe Takayasu arteritis characterized by high blood pressure and significant vascular involvement.

Not a fit: Patients with severe organ insufficiency or other autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from severe Takayasu arteritis.

How similar studies have performed: While previous studies have explored treatments for Takayasu arteritis, this approach of directly comparing two biological agents in severe cases is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. age≥14 years old;
2. active: Kerr score≥ 2;
3. severe:

   1. Blood pressure \> 180/110mmHg;
   2. ≥ 3 branches with the stenotic rate \> 70% involved;
   3. high degree of organ insufficiency: NYHF III\~IV; eGFR (MRDR) 15\~ 60ml/min;

Exclusion Criteria:

1. Severe organ insufficiency;
2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;
3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;
4. malignant tumors;
5. history of severe drug allergy;
6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Rheumatology in Zhongshan hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Rongyi Chen, PhD

Conditions Takayasu Arteritis; Tocilizumab; Adalimumab; Treatment; treatment