Juvenile Idiopathic ArthritisNCT07083466
Assessment of Composite Inflammatory Ratios in Juvenile Idiopathic Arthritis and Their Association With Disease Activity
An observational study of Juvenile Idiopathic Arthritis, run by Sohag University.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- complete blood count and serum albumin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- -
- 1. Patients who classified JIA according to International League of Associations for Rheumatology ILAR criteria on treatment with exclusion of systemic JIA.
- 2. 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
Who cannot join
- 1. 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
osama S Daifallah, AssistantProf contact
About this study
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) .
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- complete blood count, serum albumin
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood countDiagnostic test
blood test
serum albuminDiagnostic test
blood test
| Study group | Role | What they receive |
|---|---|---|
| case | cases under 16y established diagnosis juvenile idiopathic arthritis Receives: Diagnostic Test: complete blood count; Diagnostic Test: serum albumin | |
| control | below age 16 y not diagnosed with any autoimmune or systemic disease Receives: Diagnostic Test: complete blood count; Diagnostic Test: serum albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
possibility to use crp to albumin level as novel biomarker to predict disease activity in juvenile 0idiopathic arthritis
Measured: 6 months
possibility to detect systemic inflammatory index and its relation to disease activity and risk of flare in juvenile idiopathic arthritis
Measured: 6 months
assessment of activity of disease according to JDAS SCORE
Measured: 6 months
assessment of neutrophils to albumin ratio and its relation to JDAS score activity score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Fadlalmawla Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083466
- Sponsor's protocol ID
- Soh-Med-25-6-6MS
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22483423Prakken B, Albani S, Martini A. Juvenile idiopathic arthritis. Lancet. 2011 Jun 18;377(9783):2138-49. doi: 10.1016/S0140-6736(11)60244-4.
PubMed 21684384Milovanovic 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.
PubMed 15115702Erre 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.
PubMed 30316204
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Composite Inflammatory Ratios in Juvenile Idiopathic Arthritis and Their Association With Disease Activity
- ClinicalTrials.gov ID
- NCT07083466
- Acronym / sponsor ID
- Soh-Med-25-6-6MS
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Diagnostic Test: complete blood count, Diagnostic Test: serum albumincases under 16y established diagnosis juvenile idiopathic arthritis |
| control | – | Diagnostic Test: complete blood count, Diagnostic Test: serum albuminbelow age 16 y not diagnosed with any autoimmune or systemic disease |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- -
- 1. Patients who classified JIA according to International League of Associations for Rheumatology ILAR criteria on treatment with exclusion of systemic JIA.
- 2. 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
Key exclusion criteria (2 listed)
- 1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complete blood countblood test | Diagnostic test | case, control |
| serum albuminblood test | Diagnostic test | case, control |
Primary outcome
possibility to use crp to albumin level as novel biomarker to predict disease activity in juvenile 0idiopathic arthritis
Time frame: 6 months
possibility to detect systemic inflammatory index and its relation to disease activity and risk of flare in juvenile idiopathic arthritis
Time frame: 6 months
assessment of activity of disease according to JDAS SCORE
Time frame: 6 months
assessment of neutrophils to albumin ratio and its relation to JDAS score activity score
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 22483423Huang JL. New advances in juvenile idiopathic arthritis. Chang Gung Med J. 2012 Jan-Feb;35(1):1-14. doi: 10.4103/2319-4170.106171.
- Background: PubMed 21684384Prakken B, Albani S, Martini A. Juvenile idiopathic arthritis. Lancet. 2011 Jun 18;377(9783):2138-49. doi: 10.1016/S0140-6736(11)60244-4.
- Background: PubMed 15115702Milovanovic 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.
- Background: PubMed 30316204Erre 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
osama S Daifallah, AssistantProf contact
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadeer F Mohamed, resident (01030536331, hadeer.fadl@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
possibility to use crp to albumin level as novel biomarker to predict disease activity in juvenile 0idiopathic arthritis (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083466, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.