NCT07083466

Brief Summary

Juvenile Idiopathic Arthritis (JIA) is a prevalent pediatric rheumatic disorder characterized by persistent inflammation of one or more joints in children and adolescents. This chronic condition is a major contributor to both short- and long-term morbidity and functional disability We aim in this study to investigate the role of CAR, PLR, NLR ,systemic inflammatory index (SII ) and NAR ( SII and NAR have never been evaluated before in JIA patients ) as potential markers of disease activity in patients with non-systemic JIA (nsJIA) .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 27, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

July 24, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

June 27, 2025

Last Update Submit

July 16, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • possibility to use crp to albumin level as novel biomarker to predict disease activity in juvenile 0idiopathic arthritis

    6 months

  • possibility to detect systemic inflammatory index and its relation to disease activity and risk of flare in juvenile idiopathic arthritis

    6 months

  • assessment of activity of disease according to JDAS SCORE

    6 months

  • assessment of neutrophils to albumin ratio and its relation to JDAS score activity score

    6 months

Study Arms (2)

case

cases under 16y established diagnosis juvenile idiopathic arthritis

Diagnostic Test: complete blood countDiagnostic Test: serum albumin

control

below age 16 y not diagnosed with any autoimmune or systemic disease

Diagnostic Test: complete blood countDiagnostic Test: serum albumin

Interventions

complete blood countDIAGNOSTIC_TEST

blood test

casecontrol
serum albuminDIAGNOSTIC_TEST

blood test

casecontrol

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study will include 60 patients classified as JIA according International League of Associations for Rheumatology ILAR criteria on treatment who will recruited from Rheumatology and Rehabilitation department at Sohag University hospital in addition to 30 healthy individual volunteers without history of any systemic active disease recruited from the community as age and sex matched controls

You may qualify if:

  • \. Patients with disease duration more than 6 months. 3. Age below 16 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent or their parents/guardians

You may not qualify if:

  • \. Systemic JIA. 2. Patients with other autoimmune or autoinflammatory diseases, immunodeficiencies, hematologic conditions, malignances and infectious disease at enrollment time or in the previous 2 weeks.
  • Patients who are not able and willing to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Huang JL. New advances in juvenile idiopathic arthritis. Chang Gung Med J. 2012 Jan-Feb;35(1):1-14. doi: 10.4103/2319-4170.106171.

    PMID: 22483423BACKGROUND
  • Prakken B, Albani S, Martini A. Juvenile idiopathic arthritis. Lancet. 2011 Jun 18;377(9783):2138-49. doi: 10.1016/S0140-6736(11)60244-4.

    PMID: 21684384BACKGROUND
  • Milovanovic M, Nilsson E, Jaremo P. Relationships between platelets and inflammatory markers in rheumatoid arthritis. Clin Chim Acta. 2004 May;343(1-2):237-40. doi: 10.1016/j.cccn.2003.12.030.

    PMID: 15115702BACKGROUND
  • Erre GL, Paliogiannis P, Castagna F, Mangoni AA, Carru C, Passiu G, Zinellu A. Meta-analysis of neutrophil-to-lymphocyte and platelet-to-lymphocyte ratio in rheumatoid arthritis. Eur J Clin Invest. 2019 Jan;49(1):e13037. doi: 10.1111/eci.13037. Epub 2018 Nov 6.

    PMID: 30316204BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Hadeer F Mohamed, resident

CONTACT

osama S Daifallah, AssistantProf

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at rheumatology and rehabilitation department at sohag university hospitals

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 24, 2025

Study Start

July 15, 2025

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

July 24, 2025

Record last verified: 2025-06