Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome
Recruiting
Phase 2Interventional Study
AneurysmBehcet Syndrome, Vascular Type
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
81 (estimated)
Sponsor
Peking Union Medical College Hospital · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 wit…
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.
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