A Phase 2 interventional study of Adalimumab plus Methotrexate in Uveitis, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-12-28.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
The aim of this study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis.
Although non-infectious uveitis is rare in pediatric population, the irreversible visual impairment due to ocular complications, severe drug adverse effects are disturbing. There is a high rate of chronic disorder of ocular inflammation and unresponsiveness of therapy drugs in pediatric uveitis, which result in structure destruction and functional impairment including band keratopathy, posterior synechiae, cataract, and so on. The systemic and topical glucocorticoid are advocated to control inflammation but carry a high risk of lots of advert events.
Methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis. it was benefit to prolong remission and reduce recurrence. However, despite early intervention 27-48% children do not achieve control of inflammation and 20% experience adverse events. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of many rheumatic diseases. ADA as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis, a better visual acuity and a lower dose of dosage of daily glucocorticoid.
The investigators propose to test the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year.
335 studies on the registry are indexed under Uveitis; 37 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 208 interventional studies indexed under Uveitis.
Browse Uveitis studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Adalimumab plus Methotrexate
Adalimumab 40 mg (≥30kg weight) or 20mg (\<30kg weight) subcutaneously every other week without loading dose. Methotrexate(10 to 20 mg per square meter of body-surface area; maximum dose, 20 mg) .
the time to reach the remission
Time frame: 12 months
the time of a first relapse once remission
Time frame: 12 months
macular structure
decrease of central foveal thickness
Time frame: 12 months
the total dosage of corticosteriod or the time to steroid discontinuation
Time frame: 12 months
Best corrected visual Acuityand
increase of BCVA
Time frame: 12 months
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University