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Recruiting Phase 2 NCT05845723

Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome

Trial Parameters

Condition Aneurysm
Sponsor Peking Union Medical College Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 81
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-06-01
Completion 2026-06-01
Interventions
tocilizumabtofacitinibcyclophosphamide

Brief Summary

This project aims to evaluate the efficacy and safety of the combination of glucocorticoids with tocilizumab or tofacitinib, compared to the traditional combination of glucocorticoids with cyclophosphamide in the treatment of vascular Behçet's syndrome.

Eligibility Criteria

Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted. 2\. Male and female subjects aged 18-65 years. 3. Fulfill the 2013 International Classification Criteria for Behcet's Disease (ICBD). 4. Patients with aneurysmal dilatation/aneurysm of the descending aorta and/or peripheral arteries confirmed by ultrasonography and/or computed tomography angiography (CTA). 5\. Elevated acute phase reactants ESR and hs-CRP. Exclusion Criteria: 1. Cardiovascular manifestations that cannot be distinguished from giant cell arteritis, Burger's disease, or atherosclerotic aneurysm; infectious aneurysm; 2. Other active organ involvement related to BS that requires intensified immunosuppressive treatment, including gastrointestinal ulcers, uveitis, and parenchymal neurological involvement; 3. Patients with severe aneurysms requiring emergency intervention surgery; patients with elective surgery indications require t

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