Clinical trial NCT05540743: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Juvenile Idiopathic Arthritis Associated Uveitis
Keywords: Biologics
JIA-U
Uveitis
Pediatrics
adalimumab
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 In a cohort study from Cairo University Pediatric Hospital, JIA accounted for 39% of all cases of pediatric uveitis (unpublished data).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

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)

Primary outcomes:
measure: steroids sparing effect of the drug
timeFrame: 24 months
measure: the severity and complications of the uveitis
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo university
Study officials:
affiliation: KAsrAlaliny
name: Mai Nasser
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Qian Y, Acharya NR. Juvenile idiopathic arthritis-associated uveitis. Curr Opin Ophthalmol. 2010 Nov;21(6):468-72. doi: 10.1097/ICU.0b013e32833eab83.
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.
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.
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.