Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588818
• Other study ID #: 2020-ADA-Uveitis
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: Dan Liang, MD
• Phone: 0086-20-87330402
• Email: liangd2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Adalimumab 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) .

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to reach the remission		12 months
Secondary	the time of a first relapse once remission		12 months
Secondary	macular structure	decrease of central foveal thickness	12 months
Secondary	the total dosage of corticosteriod or the time to steroid discontinuation		12 months
Secondary	Best corrected visual Acuityand	increase of BCVA	12 months