Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis
Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 28, 2021
December 1, 2021
3.9 years
October 9, 2020
December 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the time to reach the remission
12 months
Secondary Outcomes (4)
the time of a first relapse once remission
12 months
macular structure
12 months
the total dosage of corticosteriod or the time to steroid discontinuation
12 months
Best corrected visual Acuityand
12 months
Study Arms (1)
Adalimumab plus Methotrexate
EXPERIMENTALInterventions
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) .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Related Publications (1)
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.
PMID: 37172782DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Liang, MD
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D
Study Record Dates
First Submitted
October 9, 2020
First Posted
October 19, 2020
Study Start
February 1, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
December 28, 2021
Record last verified: 2021-12