Efficacy and Safety of Tocilizumab and Tofacitinib in the Treatment of Patients With Vascular Behçet's Syndrome
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Jinjing Liu, M.D.
wingsforjane@163.com
8613581605769
Backup
Wenjie Zheng, M.D.
wenjzheng@gmail.com
8613661281939
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 81
Treatments
Experimental: Tocilizumab+GCS for VBS
Participants randomized to this arm will receive prednisone 1mg/kg/d, gradually tapered to 10mg/d at week 12, combined with intravenous infusion of tocilizumab 8mg/kg every 4 weeks for 24 weeks.
Experimental: Tofacitinib+GCS for VBS
Participants randomized to this arm will receive prednisone 1mg/kg/d, gradually tapered to 10mg/d at week 12, combined with oral tofacitinib 5mg twice a day for 24 weeks of treatment.
Experimental: Cyclophosphamide+GCS for VBS
Participants randomized to this arm will receive prednisone 1mg/kg/d, gradually tapered to 10mg/d at week 12, combined with intravenous infusion of cyclophosphamide 0.5g biweekly for 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital