Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis

ConditionUveitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking Union Medical College Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Adalimumab plus different doses of oral glucocorticosteroid

    Drug

    A 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

130 Participants
are divided into 2 treatment groups
Group A: Medium dose group (Adalimumab plus medium dose oral glucocorticosteroid)Experimental treatment 1 intervention
Group B: High dose group (Adalimumab plus high dose oral glucocorticosteroid)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 months

Secondary outcomes

1

Best corrected visual acuity (BCVA)

BCVA was transformed into logMar form

Time frame
3 months
2

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

Time frame
3 months
3

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

Time frame
3 months
4

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

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: