Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

Phase 2

• Conditions: Uveitis
• Interventions: Drug: Adalimumab plus Methotrexate

• Registration Number: NCT04588818
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-26
• Last Update Posted: 2021-12-28
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab plus Methotrexate	Adalimumab plus Methotrexate	-

Primary Outcome Measures

Name	Time	Method
the time to reach the remission	12 months

Secondary Outcome Measures

Name	Time	Method
macular structure	12 months	decrease of central foveal thickness
the time of a first relapse once remission	12 months
the total dosage of corticosteriod or the time to steroid discontinuation	12 months
Best corrected visual Acuityand	12 months	increase of BCVA

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China