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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Apr 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe a combination of two medications, tocilizumab and tofacitinib, is when used with glucocorticoids (a type of steroid) in treating vascular Behçet's syndrome, a condition that can cause aneurysms (bulging blood vessels). Researchers want to see if this new combination works better than the traditional treatment that uses glucocorticoids with another drug called cyclophosphamide. The trial is currently recruiting participants aged 18 to 65 who have been diagnosed with Behçet's disease and have specific types of aneurysms confirmed by imaging tests.

To take part in the study, participants need to sign a consent form and meet certain health criteria, such as having elevated inflammatory markers in the blood. However, individuals with certain severe health issues, active infections, or those who have recently used other immunosuppressive medications may not be eligible. If you join the trial, you can expect regular visits to monitor your health and any side effects from the medications. This study aims to find better treatment options for people dealing with this challenging condition.

Gender

ALL

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 the consensus between rheumatologists and vascular surgeons to determine inclusion or exclusion.
• • 4. Severe organ dysfunction, including ALT, AST, and TBIL exceeding the upper limit of normal by more than 2 times, serum creatinine ≥ 133 mmol/L, white blood cell count \< 3×10\^9/L, ANC \< 2×10\^9/L, hemoglobin \< 80g/L, platelet count \< 100×10\^9/L;
• • 5. Active infection such as active tuberculosis, hepatitis B or C, syphilis, chronic EBV infection, persistent or severe bacterial or viral infection;
• • 6. Primary or secondary immunodeficiency;
• • 7. Malignant tumor;
• • 8. Use of immunosuppressants such as Cyclosporin A (CsA), Azathioprine (AZA), Tacrolimus (TAC), Mycophenolate Mofetil (MMF), or Cyclophosphamide (CTX) within 1 month;
• • 9. Use of biologics/small molecule drugs within 5 half-lives (baricitinib within 10 days; etanercept within 4 weeks; infliximab within 8 weeks; adalimumab, golimumab, ustekinumab, and abatacept within 10 weeks, secukinumab within 6 months, and previously use of tocilizumab and tofacitinib);
• • 10. Pregnant, lactating, or planning a recent pregnancy;
• • 11. Subjects who do not agree to or are unable to comply with regular visits.