Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role
in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking
monoclonal antibody efficacious and safe as treatment of adult-onset SpA.
In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients
with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and
that it will be well tolerated. At the end of this phase, patients will go into a 52-week
open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We
will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy
will be assessed by counting the number of actively inflamed joints and a number of other
parameters.