Biologic Therapy in Pediatric JIA Uveitis

Phase 4

Active, not recruiting

• Conditions: Juvenile Idiopathic Arthritis Associated Uveitis
• Interventions: Drug: biologic DMARDs

• Registration Number: NCT05540743
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

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 In a cohort study from Cairo University Pediatric Hospital, JIA accounted for 39% of all cases of pediatric uveitis (unpublished data).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 Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-01
• Last Update Posted: 2022-10-04
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JIA associated uveitis	biologic DMARDs	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.

Primary Outcome Measures

Name	Time	Method
the severity and complications of the uveitis	24 months	degree of clinical improvement by clinical examination
steroids sparing effect of the drug	24 months	reduction in the dosage/frequency of topical and systemic steroids

Trial Locations

Locations (1)

Faculty of medicine, Cairo university; 🇪🇬 Cairo, Egypt