Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis
Primary Purpose
Uveitis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Adalimumab plus Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis focused on measuring Pediatric Panuveitis, Methotrexate, Adalimumab
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
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adalimumab plus Methotrexate
Arm Description
Outcomes
Primary Outcome Measures
the time to reach the remission
Secondary Outcome Measures
the time of a first relapse once remission
macular structure
decrease of central foveal thickness
the total dosage of corticosteriod or the time to steroid discontinuation
Best corrected visual Acuityand
increase of BCVA
Full Information
NCT ID
NCT04588818
First Posted
October 9, 2020
Last Updated
December 26, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04588818
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
Pediatric Panuveitis, Methotrexate, Adalimumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab plus Methotrexate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adalimumab plus Methotrexate
Intervention Description
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) .
Primary Outcome Measure Information:
Title
the time to reach the remission
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the time of a first relapse once remission
Time Frame
12 months
Title
macular structure
Description
decrease of central foveal thickness
Time Frame
12 months
Title
the total dosage of corticosteriod or the time to steroid discontinuation
Time Frame
12 months
Title
Best corrected visual Acuityand
Description
increase of BCVA
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Liang, MD
Phone
0086-20-87330402
Email
liangd2@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Liang, MD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liang, MD
Phone
0086-20-87330402
Email
liangd2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Dan Liang, MD
12. IPD Sharing Statement
Learn more about this trial
Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis
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