Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

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Brief Title

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

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

the time to reach the remission

Secondary Outcome

 the time of a first relapse once remission

Condition

Uveitis

Intervention

Adalimumab plus Methotrexate

Study Arms / Comparison Groups

 Adalimumab plus Methotrexate
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

February 1, 2020

Completion Date

February 1, 2021

Primary Completion Date

February 1, 2021

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
      

Gender

All

Ages

2 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Dan Liang, MD, 0086-20-87330402, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04588818

Organization ID

2020-ADA-Uveitis


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Dan Liang, MD, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University


Verification Date

October 2020