Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome
Recruiting now · Phase 2
Conditions studied: Aneurysm, Behcet Syndrome, Vascular Type
In brief
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.
Key facts
- Study ID
- NCT05845723
- Run by
- Peking Union Medical College Hospital
- People needed
- 81
- Starts
- 2023-06-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2024-08-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1． Understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
- 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).
- Elevated acute phase reactants ESR and hs-CRP.
You may not qualify if…
- Cardiovascular manifestations that cannot be distinguished from giant cell arteritis, Burger's disease, or atherosclerotic aneurysm; infectious aneurysm;
- Other active organ involvement related to BS that requires intensified immunosuppressive treatment, including gastrointestinal ulcers, uveitis, and parenchymal neurological involvement;
- 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.
- 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;
- Active infection such as active tuberculosis, hepatitis B or C, syphilis, chronic EBV infection, persistent or severe bacterial or viral infection;
- Primary or secondary immunodeficiency;
- Malignant tumor;
- Use of immunosuppressants such as Cyclosporin A (CsA), Azathioprine (AZA), Tacrolimus (TAC), Mycophenolate Mofetil (MMF), or Cyclophosphamide (CTX) within 1 month;
- 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);
- Pregnant, lactating, or planning a recent pregnancy;
- Subjects who do not agree to or are unable to comply with regular visits.
Where it is running
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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