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Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

NCT ID: NCT04588818

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Uveitis

Keywords

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Pediatric Panuveitis Methotrexate Adalimumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adalimumab plus Methotrexate

Group Type EXPERIMENTAL

Adalimumab plus Methotrexate

Intervention Type DRUG

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) .

Interventions

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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) .

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Dan Liang

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dan Liang, MD

Role: CONTACT

Phone: 0086-20-87330402

Email: [email protected]

Facility Contacts

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Dan Liang, MD

Role: primary

References

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Teabagy S, Wood E, Bilsbury E, Doherty S, Janardhana P, Lee DJ. Ocular immunosuppressive microenvironment and novel drug delivery for control of uveitis. Adv Drug Deliv Rev. 2023 Jul;198:114869. doi: 10.1016/j.addr.2023.114869. Epub 2023 May 10.

Reference Type DERIVED
PMID: 37172782 (View on PubMed)

Other Identifiers

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2020-ADA-Uveitis

Identifier Type: -

Identifier Source: org_study_id