RECRUITINGPhase 2INTERVENTIONAL
Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome
Efficacy and Safety of Tocilizumab and Tofacitinib in the Treatment of Patients With Vascular Behçet's Syndrome
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Understand and voluntarily sign an willing to sign a consent form 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.
Who Should NOT Join This Trial:
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 weakened immune system;
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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
tocilizumab
Participants will receive intravenous infusion of tocilizumab 8mg/kg every 4 weeks for 24 weeks.
DRUG
tofacitinib
Participants will receive tofacitinib 5mg twice a day for 24 weeks of treatment.
DRUG
cyclophosphamide
Participants will receive intravenous infusion of cyclophosphamide 0.5g biweekly for 24 weeks.
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China