NCT01693653

Tocilizumab for the Treatment of Behcet's Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Behcet Syndrome

Interventions

Type	Name	Description
DRUG	Tocilizumab	Intravenous infusions every 4 weeks for 3 doses.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-09-26
• Last updated: 2019-02-15
• Results posted: 2016-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study