Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    30
  • sponsor
    Sun Yat-sen University
Updated on 9 January 2022
methotrexate
adalimumab
panuveitis

Summary

The aim of this study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis.

Description

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.

Details
Condition Uveitis
Treatment Adalimumab plus Methotrexate
Clinical Study IdentifierNCT04588818
SponsorSun Yat-sen University
Last Modified on9 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of non-infectious panuveitis
Age from 2 to 16 years old
Vision threatening non-infectious uveitis hadn't received standardized systematic treatment before

Exclusion Criteria

Patients who had active infection (including hepatitis B or C infection, tuberculosis), malignancy diseases, or bilateral irreversible blindness and any other contraindications of ADA
previous exposure to another biologic agent
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