Tocilizumab for the Treatment of Behcet's Syndrome

Conditions

• Behcet Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
  Intravenous infusions every 4 weeks for 3 doses.

Study Details

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.

Key Dates

Start date

Sep 30, 2012

Status verified

Feb 2019

Primary completion

Nov 30, 2013

Completion

Nov 30, 2013

Study Design

Enrollment

1 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Tocilizumab
  tocilizumab infusion every 4 weeks over 3 months
• Placebo Comparator: Placebo
  placebo infusion 0.9% sodium chloride every 4 weeks over 3 months

Primary Outcome Measure

Primary Outcome [ Time Frame: 9 months ]

Locations (1)

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