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Biologic Therapy in Pediatric JIA Uveitis

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05540743
Collaborator
(none)
250
Enrollment
1
Location
1
Arm
21
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: biologic DMARDs
 Phase 4

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 In a cohort study from Cairo University Pediatric Hospital, JIA accounted for 39% of all cases of pediatric uveitis (unpublished data).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

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Anti-TNF Alpha Agents in the Treatment of JIA- Associated Uveitis in a Pediatric Cohort
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. steroids sparing effect of the drug [24 months]

      reduction in the dosage/frequency of topical and systemic steroids

    2. the severity and complications of the uveitis [24 months]

      degree of clinical improvement by clinical examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    • 1.Patients without definitive diagnosis as JIA 2. JIA patients on biologics without ocular affection (for systemic control) or with uveitis controlled without the use of biologics 3.Patients without adequate duration for follow-up (less than 3 months) or lost follow up data 4.Patients without available data prior to the start biologics (to compare control of the uveitis)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine, Cairo university Cairo Egypt 11562

    Sponsors and Collaborators

    • Kasr El Aini Hospital

    Investigators

    • Principal Investigator: Mai Nasser, KAsrAlaliny

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Mai Nasser Abd Elmohsen, lecturer of ophthalmology, Kasr El Aini Hospital
    ClinicalTrials.gov Identifier:
    NCT05540743
    Other Study ID Numbers:
    • N-50-2020
    First Posted:
    Sep 15, 2022
    Last Update Posted:
    Sep 15, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Mai Nasser Abd Elmohsen, lecturer of ophthalmology, Kasr El Aini Hospital
    Biologics, JIA-U, uveitis, pediatrics, adalimumab
    Additional relevant MeSH terms:
    Arthritis, Juvenile
    Uveitis
    Adalimumab

    Study Results

    No Results Posted as of Sep 15, 2022