Evaluating treatments for severe Takayasu arteritis
Official title: A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort
Run by Shanghai Zhongshan Hospital · NCT04300686 · Data updated 2026-11-12
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 |
| Ages | 14 Years to 100 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | tocilizumab, adalimumab, tofacitinib, methotrexate, prednisone |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 1, 2020 |
| Main results expected | May 1, 2022 |
| Study ends | December 31, 2023 |
| Registry record updated | August 10, 2021 |
| Trial ID | NCT04300686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe organ insufficiency or other autoimmune diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While previous studies have explored treatments for Takayasu arteritis, this approach of directly comparing two biological agents in severe cases is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Department of Rheumatology in Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Rongyi Chen, PhD
- Email: chenry825@hotmail.com
- Phone: +8615221160538
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.