Biologic Therapy in Pediatric JIA Uveitis

October 1, 2022 updated by: Mai Nasser Abd Elmohsen, Kasr El Aini Hospital

The Efficacy of Anti-TNF Alpha Agents in the Treatment of JIA- Associated Uveitis in a Pediatric Cohort

Juvenile Idiopathic Arthritis (JIA) remains the most common systemic disorder associated with pediatric uveitis. Studies estimate that 28-67% of patients with JIA-associated uveitis develop ocular complications, with 12% developing poor visual outcome. The only means of improving long term effects of uveitis, is early and aggressive anti-inflammatory treatment, including biologics.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Juvenile Idiopathic Arthritis (JIA) remains, globally, the most common systemic disorder associated with pediatric uveitis consisting 75% of anterior uveitis cases (AU)1. In a cohort study from Cairo University Pediatric Hospital, JIA accounted for 39% of all cases of pediatric uveitis (unpublished data). Studies estimate that 28-67% of patients with JIA-U develop ocular complications, with 12% developing poor visual outcome2,3,4. Thus, early and aggressive anti-inflammatory treatment is the only means of improving long term effects of uveitis5-7.

In 2019, the American College of Rheumatology/Arthritis Foundation recommended, that in severe, active, chronic AU or in the presence of sight-threatening complications, methotrexate (MTX) and a monoclonal antibody Tumor Necrosis Factor inhibitor (TNFi) should be immediately administered8. Biologic drugs act against specific cytokines or their receptors, in order to reduce tissue damage9. Currently, infliximab, and adalimumab are the main TNF inhibitors available for children10 and are used in the treatment of refractory or chronic childhood uveitis 11,12 . Our study aims to analyze the value and outcome of using biologics at Abou el Reesh, Cairo University Hospital, being a main tertiary referral center in Egypt for children with JIA-U.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Faculty of Medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed JIA according to rheumatological criteria with ocular affection
  • Any type of arthritis (oligoarticular, polyarticular, systemic onset, ocular JIA)
  • ANA positive or negative
  • Uncontrolled uveitis or frequent relapses

Exclusion Criteria:

  • Patients without definitive diagnosis as JIA
  • JIA patients on biologics without ocular affection (for systemic control) or with uveitis controlled without the use of biologics
  • Patients without adequate duration for follow-up (less than 3 months) or lost follow up data
  • Patients without available data prior to the start biologics (to compare control of the uveitis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: JIA associated uveitis
patients diagnosed with Juvenile idiopathic arthritis and uveitis taking immunosuppression including biologics 9of any type according to their rheumatologist recommendations) for control of their autoimmune uveitis.
Drug: biologic DMARDs
follow up the clinical response in Egyptian population to the drug
Other Names:
  • rimicade, adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
steroids sparing effect of the drug
Time Frame: 24 months
reduction in the dosage/frequency of topical and systemic steroids
24 months
the severity and complications of the uveitis
Time Frame: 24 months
degree of clinical improvement by clinical examination
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Mai Nasser, KAsrAlaliny

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-50-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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