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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05845723
Phase
PHASE2
Status
Recruiting
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Conditions

  • Aneurysm
  • Behcet Syndrome, Vascular Type

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • tocilizumab — DRUG
    Participants will receive intravenous infusion of tocilizumab 8mg/kg every 4 weeks for 24 weeks.
  • tofacitinib — DRUG
    Participants will receive tofacitinib 5mg twice a day for 24 weeks of treatment.
  • cyclophosphamide — DRUG
    Participants will receive intravenous infusion of cyclophosphamide 0.5g biweekly for 24 weeks.

Study Details

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 Dates

Start date
Jun 1, 2023
Status verified
Jul 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The primary endpoint is the complete response (CR) rate at week 12. [ Time Frame: Baseline to week 12 ]

Central Contacts

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