Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis
Status:
Completed
Trial end date:
2015-08-27
Target enrollment:
Participant gender:
Summary
The investigators propose to study the efficacy of adalimumab versus placebo (double-blind
randomization on inclusion into 2 equal groups) on reduction of ocular inflammation
quantified by laser flare photometry after two months of treatment in patients with active
uveitis despite well conducted treatment with steroid eye drops and MTX. The primary
objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus
the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2
months after inclusion, presents at least 30% reduction of inflammation on laser flare
photometry and improvement or a stable appearance on slit lamp examination. After the second
month, all patients wishing to continue the trial and presenting a satisfactory clinical
state will be treated with adalimumab for a total of one year after inclusion to
descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.