Conditions: Behcet Syndrome
Keywords: Behcet's syndrome oral ulcers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief summary:
This is a double-blind placebo controlled study targeting individuals with active Behcet's Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable dose for 4 weeks before enrollment. Prednisone or equivalent (\< 10mg/day) permitted if dose stable for 6 weeks prior to enrollment.

The study will investigate the safety of tocilizumab for this vasculitic condition in addition to its efficacy.

The planned sample size is 30 participants per arm for a total of 60 participants. The study would be for 3 months, with a safety follow up at 2 months after study termination.

Study participants will stay on their current treatments and either tocilizumab or placebo infusions will be given every 4 weeks in addition. Patients will be randomized to Actemra IV 8mg/kg Q 4 weeks X 3 doses or placebo.

Detailed description:
Behcet's syndrome is a vasculitis that causes oral and genital ulcerations, skin lesions, eye disease and arthritis, in addition to vascular complications with thrombophlebitis, thrombosis and rarely central nervous system involvement. IL-6 activity has been suggested in the pathogenesis in some studies. Tocilizumab with its unique mode of action among biologic agents may be a good candidate in this orphan disease.

Arms:
arm 1: tocilizumab infusion every 4 weeks over 3 months arm 2: placebo infusion 0.9% sodium chloride every 4 weeks over 3 months

Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: Intravenous infusions every 4 weeks for 3 doses.

Protocol document: