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Biologic Therapy in Pediatric JIA Uveitis

Primary Purpose

Juvenile Idiopathic Arthritis Associated Uveitis

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
biologic DMARDs
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis Associated Uveitis focused on measuring Biologics, JIA-U, Uveitis, Pediatrics, adalimumab

Eligibility Criteria

3 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of medicine, Cairo university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

JIA associated uveitis

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2022
Last Updated
October 1, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05540743
Brief Title
Biologic Therapy in Pediatric JIA Uveitis
Official Title
The Efficacy of Anti-TNF Alpha Agents in the Treatment of JIA- Associated Uveitis in a Pediatric Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis Associated Uveitis
Keywords
Biologics, JIA-U, Uveitis, Pediatrics, adalimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JIA associated uveitis
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
biologic DMARDs
Other Intervention Name(s)
rimicade, adalimumab
Intervention Description
follow up the clinical response in Egyptian population to the drug
Primary Outcome Measure Information:
Title
steroids sparing effect of the drug
Description
reduction in the dosage/frequency of topical and systemic steroids
Time Frame
24 months
Title
the severity and complications of the uveitis
Description
degree of clinical improvement by clinical examination
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Nasser
Organizational Affiliation
KAsrAlaliny
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Cairo university
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17362866
Citation
Thorne JE, Woreta F, Kedhar SR, Dunn JP, Jabs DA. Juvenile idiopathic arthritis-associated uveitis: incidence of ocular complications and visual acuity loss. Am J Ophthalmol. 2007 May;143(5):840-846. doi: 10.1016/j.ajo.2007.01.033. Epub 2007 Mar 23.
Results Reference
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PubMed Identifier
20729734
Citation
Qian Y, Acharya NR. Juvenile idiopathic arthritis-associated uveitis. Curr Opin Ophthalmol. 2010 Nov;21(6):468-72. doi: 10.1097/ICU.0b013e32833eab83.
Results Reference
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PubMed Identifier
16825275
Citation
Doycheva D, Deuter C, Stuebiger N, Biester S, Zierhut M. Mycophenolate mofetil in the treatment of uveitis in children. Br J Ophthalmol. 2007 Feb;91(2):180-4. doi: 10.1136/bjo.2006.094698. Epub 2006 Jul 6.
Results Reference
background
PubMed Identifier
21423146
Citation
Chang PY, Giuliari GP, Shaikh M, Thakuria P, Makhoul D, Foster CS. Mycophenolate mofetil monotherapy in the management of paediatric uveitis. Eye (Lond). 2011 Apr;25(4):427-35. doi: 10.1038/eye.2011.23. Epub 2011 Mar 18.
Results Reference
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PubMed Identifier
31021511
Citation
Angeles-Han ST, Ringold S, Beukelman T, Lovell D, Cuello CA, Becker ML, Colbert RA, Feldman BM, Holland GN, Ferguson PJ, Gewanter H, Guzman J, Horonjeff J, Nigrovic PA, Ombrello MJ, Passo MH, Stoll ML, Rabinovich CE, Sen HN, Schneider R, Halyabar O, Hays K, Shah AA, Sullivan N, Szymanski AM, Turgunbaev M, Turner A, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Screening, Monitoring, and Treatment of Juvenile Idiopathic Arthritis-Associated Uveitis. Arthritis Rheumatol. 2019 Jun;71(6):864-877. doi: 10.1002/art.40885. Epub 2019 Apr 25.
Results Reference
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Biologic Therapy in Pediatric JIA Uveitis

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