About this trial
This study is a multi-center randomized non-inferiority study that aims to observe the short-term (3 months) efficacy and safety of adalimumab plus medium-dose glucocorticosteroid (30mg/d prednisone or equivalent) with slow tapering for recurrent Behçet's uveitis (BU) attack compared with adalimumab plus high-dose glucocorticosteroid (60mg/d prednisone or equivalent) with slow tapering.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Behçet's disease (BD) patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis
The patient should be on ≥10mg/d oral prednisone or equivalent
Disqualifiers
Previous treatment with TNFα inhibitors within 3 months
Pregnancy, breast feeding women
Malignancy
Heart failure
Trial design
Parallel
Treatments tested in this trial
Adalimumab plus different doses of oral glucocorticosteroid
DrugA loading dose of 80mg adalimumab will be given subcutaneously and then change to 40mg adalimumab every two weeks. Medium dose oral glucocorticosteroid (30mg/d prednisone or equivalent) will be given to the experimental dose group and high dose oral glucocorticosteroid (60mg/d prednisone or equivalent) will be given to the high dose group.
Treatment groups
Trial outcomes
Primary outcomes
Uveitis control
Inflammation control according to SUN criteria (two steps decrease of anterior chamber cell or vitreous haze or decreased to zero) or active retinal lesion recession with vitreous haze less than 0.5 grade
Secondary outcomes
Best corrected visual acuity (BCVA)
BCVA was transformed into logMar form
Extent of vascular leakage
Vascular leakage was quantified based on the method developed by the Angiography Scoring for Uveitis Working Group (ASUWOG), in which vascular leakage in the posterior pole and in each peripheral quadrant was scored 1 if limited
BOS 24 score
BOS 24 scoring system refers to article "Behc et's disease ocular attack score 24: evaluation of ocular disease activity before and after initiation of infliximab
Uveitis deterioration
Inflammation deterioration according to SUN criteria (two steps increase of anterior chamber cell or vitreous haze or increases to grade 4) or new active retinal lesions or new onset of retinal vasculitis
Locations
Sponsors and contacts
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