Clinical Trial: Tocilizumab for the Treatment of Behcet's Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Tocilizumab for the Treatment of Behcet's Syndrome

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 Summary: 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.
Sponsor: New York University School of Medicine

Current Primary Outcome: Primary Outcome [ Time Frame: 9 months ]

The study was terminated. No data were collected for this Outcome Measure.


Original Primary Outcome: Primary Outcome [ Time Frame: 9 months ]

presence of oral ulcers


Current Secondary Outcome:

  • Genital Ulcers [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • Oral Ulcers [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • Treatment Failures [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • Oral Ulcer Pain [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • Gential Ulcer Pain [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • BSAS [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • MDHAQ [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • BDCAF [ Time Frame: 9 months ]
    The study was terminated. No data were collected for this outcome measure.
  • Safety [ Time Frame: 9 moths ]
    The study was terminated. No data were collected for this outcome measure.


Original Secondary Outcome:

  • Genital Ulcers [ Time Frame: 9 months ]
    mean number of genital ulcers
  • Oral Ulcers [ Time Frame: 9 months ]
    mean number of oral ulcers
  • Treatment Failures [ Time Frame: 9 months ]
    number of patients who fail to complete 3 months (treatment failures)
  • Oral Ulcer Pain [ Time Frame: 9 months ]
    mean change in oral ulcer pain VAS from baseline
  • Gential Ulcer Pain [ Time Frame: 9 months ]
    mean change in genital ulcer pain VAS
  • BSAS [ Time Frame: 9 months ]
    mean change in Behcet's syndrome activity score-BSAS
  • MDHAQ [ Time Frame: 9 months ]
    mean change in Multidimensional health assessment questionnaire-MDHAQ
  • BDCAF [ Time Frame: 9 months ]
    mean change in Behcet's disease current activity form-BDCAF scores
  • Safety [ Time Frame: 9 moths ]
    safety/tolerability measures


Information By: New York University School of Medicine

Dates:
Date Received: September 19, 2012
Date Started: September 2012
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016