JIANCT05688358
Serum Interleukin - 17A in Juvenile Idiopathic Arthritis
An observational study of JIA, run by Assiut University.
Trial summary
1. This study aims to determine the serum levels of interleukin-17A (IL-17A) in children with juvenile idiopathic arthritis (JIA) 2. Analyze the correlation between IL-17A values and disease activity, certain clinical features, and laboratory markers of inflammation. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- JIA
- What is being tested?
- serum levels of interleukin-17A in JIA
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Child
Study population: Patients less than 16 years at onset of disease and diagnosed with oligoarticular and polyarticular JIA, fulfilling the ILAR classificationcriteria of JIA.
Inclusion Criteria:_ Patients less than 16 years at onset of disease and diagnosed with oligoarticular and polyarticular JIA, fulfilling the ILAR classificationcriteria of JIA.
- Control group will include age-and-sex-matched apparently healthy children.
Exclusion Criteria: • Patients having associated neurological or disabling diseases.
- Patients with diabetes mellitus, acute or chronic infections.
- Patients with another causes of arthritis other than JIA.
Trial locations and contacts
No sites are listed yet.
About this study
- This study aims to determine the serum levels of interleukin-17A (IL-17A) in children with juvenile idiopathic arthritis (JIA)
- Analyze the correlation between IL-17A values and disease activity, certain clinical features, and laboratory markers of inflammation.
Read the detailed description
Juvenile Idiopathic Arthritis (JIA) is a group of chronic heterogenous disorders that manifests as joint inflammation in patients aged <16 years and lasts longer than 6 weeks. Globally, approximately 3 million children and young adults are suffering from JIA with prevalence rates consistently higher in girls. The prevalence of JIA in Africa and Middle East was observed to be towards the lower range of the global estimate. (1) The precise cause and pathogenesis of JIA are unknown; however, genetic, environmental, and autoimmune factors are hypothesized to play a role in its development. (2) The condition can affect one or more joints and cause systemic symptoms such as fever or rash, as well as extra-articular inflammatory signs such as uveitis.(3)
The IL-17 cytokine superfamily is composed of 6 structurally related cytokines, namely IL-17A-F. The most investigated member of the family is IL-17A. It is synthesized by Th17 cells, γδ-T cells, NK T cells, lymphoid tissue inducer-like cells, Paneth cells, and neutrophils. IL-17A plays important roles in protection from bacterial and fungal infections and in the development of autoimmune diseases (4)
Recently, a number of studies have been conducted on the role of IL-17A in the development of chronic arthritis. It has a role both at the initial stages of joint inflammation and in the destruction of joint cartilage and bone structures.(5) It binds to its receptors on synoviocytes, endothelial cells, fibroblasts and osteoblasts and stimulates production of pro-inflammatory cytokines, chemokines and other inflammatory mediators, and also, interacts synergistically with other pro- inflammatory cytokines such as IL-1, IL-6, and tumor necrosis factor alpha.(6)
- Conditions
- JIA
- Being tested
- serum levels of interleukin-17A in JIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum levels of interleukin-17A in JIADiagnostic test
IL17 A by Enzyme linked immunosorbent assay method
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Interleukin - 17A in juvenile idiopathic Arthritis
This study aims to determine the serum levels of interleukin-17A (IL-17A) in children with juvenile idiopathic arthritis (JIA)
-Analyze the correlation between IL-17A values and disease activity, certain clinical features, and laboratory markers of inflammation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JIAStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat-Allah Khaled Tolba Abdelraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688358
- Sponsor's protocol ID
- Interleukin - 17A in JIA
- Status last verified
- Jan 2023
- First submitted
- 7 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Interleukin - 17A in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05688358
- Acronym / sponsor ID
- Interleukin - 17A in JIA
- Conditions
- JIA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 18 Jan 2023 (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.
- This study aims to determine the serum levels of interleukin-17A (IL-17A) in children with juvenile idiopathic arthritis (JIA)
- Analyze the correlation between IL-17A values and disease activity, certain clinical features, and laboratory markers of inflammation.
Detailed description
Juvenile Idiopathic Arthritis (JIA) is a group of chronic heterogenous disorders that manifests as joint inflammation in patients aged <16 years and lasts longer than 6 weeks. Globally, approximately 3 million children and young adults are suffering from JIA with prevalence rates consistently higher in girls. The prevalence of JIA in Africa and Middle East was observed to be towards the lower range of the global estimate. (1) The precise cause and pathogenesis of JIA are unknown; however, genetic, environmental, and autoimmune factors are hypothesized to play a role in its development. (2) The condition can affect one or more joints and cause systemic symptoms such as fever or rash, as well as extra-articular inflammatory signs such as uveitis.(3)
The IL-17 cytokine superfamily is composed of 6 structurally related cytokines, namely IL-17A-F. The most investigated member of the family is IL-17A. It is synthesized by Th17 cells, γδ-T cells, NK T cells, lymphoid tissue inducer-like cells, Paneth cells, and neutrophils. IL-17A plays important roles in protection from bacterial and fungal infections and in the development of autoimmune diseases (4)
Recently, a number of studies have been conducted on the role of IL-17A in the development of chronic arthritis. It has a role both at the initial stages of joint inflammation and in the destruction of joint cartilage and bone structures.(5) It binds to its receptors on synoviocytes, endothelial cells, fibroblasts and osteoblasts and stimulates production of pro-inflammatory cytokines, chemokines and other inflammatory mediators, and also, interacts synergistically with other pro- inflammatory cytokines such as IL-1, IL-6, and tumor necrosis factor alpha.(6)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients less than 16 years at onset of disease and diagnosed with oligoarticular and polyarticular JIA, fulfilling the ILAR classificationcriteria of JIA.
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 |
|---|---|---|
| serum levels of interleukin-17A in JIAIL17 A by Enzyme linked immunosorbent assay method | Diagnostic test | – |
Primary outcome
Serum Interleukin - 17A in juvenile idiopathic Arthritis
Time frame: baseline
This study aims to determine the serum levels of interleukin-17A (IL-17A) in children with juvenile idiopathic arthritis (JIA) -Analyze the correlation between IL-17A values and disease activity, certain clinical features, and laboratory markers of inflammation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Interleukin-17A Levels Increase in Serum of Children With Juvenile IdiopathicLink provided by the sponsor.
Related trials for JIA
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Recruiting
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Infrared Thermography
Not yet recruitingPhase 4
Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingObservational study
Tofacitinib in Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of JIA, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennat-Allah Khaled Tolba Abdelraheem, master (0201093579968, menna.k.tolba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Interleukin - 17A in juvenile idiopathic Arthritis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.