Tocilizumab for the Treatment of Behcet's Syndrome
Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health