Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

Study Overview
=================
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.

Official Title
-----------------
Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: Adalimumab plus Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab plus Methotrexate<br> | Drug: Adalimumab plus Methotrexate<br>* 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) .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to reach the remission |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of a first relapse once remission |  | 12 months | 
| macular structure | decrease of central foveal thickness | 12 months | 
| the total dosage of corticosteriod or the time to steroid discontinuation |  | 12 months | 
| Best corrected visual Acuityand | increase of BCVA | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Panuveitis, Methotrexate, Adalimumab