Uveitis
Conditions
Keywords
Pediatric Panuveitis, Methotrexate, Adalimumab
Brief 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.
Detailed 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.
Interventions
DRUGAdalimumab 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) .
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time to reach the remission | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the time of a first relapse once remission | 12 months | — |
| macular structure | 12 months | decrease of central foveal thickness |
| the total dosage of corticosteriod or the time to steroid discontinuation | 12 months | — |
| Best corrected visual Acuityand | 12 months | increase of BCVA |
Countries
China
Contacts
Primary ContactDan Liang, MD
Outcome results
None listed