Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04588818
Collaborator
(none)
30
1
1
46.9
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Adalimumab plus Methotrexate
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adalimumab plus Methotrexate

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) .

Outcome Measures

Primary Outcome Measures

  1. the time to reach the remission [12 months]

Secondary Outcome Measures

  1. the time of a first relapse once remission [12 months]

  2. macular structure [12 months]

    decrease of central foveal thickness

  3. the total dosage of corticosteriod or the time to steroid discontinuation [12 months]

  4. Best corrected visual Acuityand [12 months]

    increase of BCVA

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dan Liang, M.D, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04588818
Other Study ID Numbers:
  • 2020-ADA-Uveitis
First Posted:
Oct 19, 2020
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Dan Liang, M.D, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2021