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Status unknownNCT05540743Updated Oct 4, 2022

Biologic Therapy in Pediatric JIA Uveitis

A Phase 4 interventional study of biologic DMARDs in Juvenile Idiopathic Arthritis Associated Uveitis, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to participants aged 3 Months to 16 Years. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by Kasr El Aini Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
3 Months to 16 Years
Sex
All
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Study 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.

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 In a cohort study from Cairo University Pediatric Hospital, JIA accounted for 39% of all cases of pediatric uveitis (unpublished data).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

02

Conditions studied

  • Juvenile Idiopathic Arthritis Associated Uveitis

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Keywords

  • Biologics
  • JIA-U
  • Uveitis
  • Pediatrics
  • adalimumab
03

In context

Uveitis

345 studies on the registry are indexed under Uveitis; 38 are open to participants now.

This study's enrollment of 250 is above the median of 30 across 214 interventional studies indexed under Uveitis.

Browse Uveitis studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 283 studies on the registry; 33 are open to participants now.

Browse Kasr El Aini Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • 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

Interventions

  • Drugbiologic DMARDs

    follow up the clinical response in Egyptian population to the drug

    Also known as: rimicade, adalimumab

06

What researchers measure

Primary outcomes

  1. steroids sparing effect of the drug

    reduction in the dosage/frequency of topical and systemic steroids

    Time frame: 24 months

  2. the severity and complications of the uveitis

    degree of clinical improvement by clinical examination

    Time frame: 24 months

07

Study locations

1 site
  • Faculty of medicine, Cairo university
    Cairo, 11562, Egypt
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References and documents

Publications

  • 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. PubMed 17362866 ↗
  • Qian Y, Acharya NR. Juvenile idiopathic arthritis-associated uveitis. Curr Opin Ophthalmol. 2010 Nov;21(6):468-72. doi: 10.1097/ICU.0b013e32833eab83. PubMed 20729734 ↗
  • 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. PubMed 16825275 ↗
  • 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. PubMed 21423146 ↗
  • 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. PubMed 31021511 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 1, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2022 (actual). Primary completion is estimated for Dec 2023, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2022
First posted
Sep 15, 2022
StartActual
Jul 1, 2022
Primary completionEst.
Dec 2023
CompletionEst.
Apr 2024
Last update
Oct 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05540743
Lead sponsor
Kasr El Aini Hospital
Responsible party
Mai Nasser Abd Elmohsen (lecturer of ophthalmology, Kasr El Aini Hospital) — Principal investigator
First posted
Sep 15, 2022
Start date
Jul 1, 2022
Primary completion
Dec 2023 (estimated)
Completion
Apr 2024 (estimated)
Last update
Oct 4, 2022

Study contacts

Mai Nasser
principal investigator · KAsrAlaliny

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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