NCT05540743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

1.4 years

First QC Date

September 12, 2022

Last Update Submit

October 1, 2022

Conditions

Juvenile Idiopathic Arthritis Associated Uveitis

Keywords

BiologicsJIA-UUveitisPediatricsadalimumab

Outcome Measures

Primary Outcomes (2)

  • steroids sparing effect of the drug

    reduction in the dosage/frequency of topical and systemic steroids

    24 months

  • the severity and complications of the uveitis

    degree of clinical improvement by clinical examination

    24 months

Study Arms (1)

JIA associated uveitis

OTHER

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

biologic DMARDsDRUG

follow up the clinical response in Egyptian population to the drug

Also known as: rimicade, adalimumab
JIA associated uveitis

Eligibility Criteria

Age3 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Cairo university

Cairo, 11562, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 17362866BACKGROUND

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

    PMID: 20729734BACKGROUND

  • 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.

    PMID: 16825275BACKGROUND

  • 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.

    PMID: 21423146BACKGROUND

  • 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.

    PMID: 31021511BACKGROUND

MeSH Terms

Conditions

Uveitis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mai Nasser

    KAsrAlaliny

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of ophthalmology

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

July 1, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)