Clinical trial NCT04588818: Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis
Official title: Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Uveitis
Keywords: Pediatric Panuveitis
Methotrexate
Adalimumab
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the time to reach the remission
timeFrame: 12 months
Secondary outcomes:
measure: the time of a first relapse once remission
timeFrame: 12 months
measure: macular structure
timeFrame: 12 months
measure: the total dosage of corticosteriod or the time to steroid discontinuation
timeFrame: 12 months
measure: Best corrected visual Acuityand
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Dan Liang, MD
role: PRINCIPAL_INVESTIGATOR
References: