Juvenile Idiopathic ArthritisNCT06024486
Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by Assiut University.
Trial summary
The fibrinogen to albumin ratio (FAR) and C-reactive protein to albumin ratio (CAR) have emerged as useful biomarkers to predict systemic inflammation. The aim here is to investigate the relation between FAR/CAR and Juvenile arthritis disease activity score (JASDAS27) in Juvenile idiopathic arthritis (JIA) 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?
- fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jul 2024
- 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
- Healthy volunteers accepted
- Child
Study population: All juvenile idiopathic arthritis fulfilling the criteria of International League of Associations for Rheumatology (ILAR) and age and sex matched healthy subjects.
Who may be able to join
- All juvenile idiopathic arthritis fulfilling the criteria of International League of Associations for Rheumatology (ILAR) and age and sex matched healthy subjects
Who cannot join
- Other systemic inflammatory or autoimmune disorders.
- History of corticosteroid medication in the last 6 months.
- Liver diseases.
- Malignancy.
About this study
Official title: Correlation of Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio With Disease Activity in Juvenile Idiopathic Arthritis
The fibrinogen to albumin ratio (FAR) and C-reactive protein to albumin ratio (CAR) have emerged as useful biomarkers to predict systemic inflammation. The aim here is to investigate the relation between FAR/CAR and Juvenile arthritis disease activity score (JASDAS27) in Juvenile idiopathic arthritis (JIA)
Read the detailed description
The JADAS27 includes a selected count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints, hips, knees and ankles.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)Diagnostic test
measurement of serum albumin, fibrinogen and CRP
| Study group | Role | What they receive |
|---|---|---|
| JIA cases | juvenile idiopathic arthritis cases Receives: Diagnostic Test: fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR) | |
| CONTROL | age and sex matched healthy controls Receives: Diagnostic Test: fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fibrinogen to albumin ratio
measurement of serum fibrinogen and albumin
Measured: 3 months
The CRP to albumin ratio
measurement of serum CRP and albumin
Measured: 3 MONTHS
Correlation of fibrinogen to albumin and CRP to albumin ratios on one side with disease activity on the other side
correlation of these ratios with JADAS27
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sayed Ibrahim Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024486
- Sponsor's protocol ID
- Juvenile arthritis assiut u
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio With Disease Activity in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT06024486
- Acronym / sponsor ID
- Juvenile arthritis assiut u
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 6 Sep 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.
The fibrinogen to albumin ratio (FAR) and C-reactive protein to albumin ratio (CAR) have emerged as useful biomarkers to predict systemic inflammation. The aim here is to investigate the relation between FAR/CAR and Juvenile arthritis disease activity score (JASDAS27) in Juvenile idiopathic arthritis (JIA)
Detailed description
The JADAS27 includes a selected count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints, hips, knees and ankles.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JIA cases | – | Diagnostic Test: fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)juvenile idiopathic arthritis cases |
| CONTROL | – | Diagnostic Test: fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)age and sex matched healthy controls |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All juvenile idiopathic arthritis fulfilling the criteria of International League of Associations for Rheumatology (ILAR) and age and sex matched healthy subjects.
Key inclusion criteria (1 listed)
- All juvenile idiopathic arthritis fulfilling the criteria of International League of Associations for Rheumatology (ILAR) and age and sex matched healthy subjects
Key exclusion criteria (4 listed)
- Other systemic inflammatory or autoimmune disorders.
- History of corticosteroid medication in the last 6 months.
- Liver diseases.
- Malignancy.
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 |
|---|---|---|
| fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)measurement of serum albumin, fibrinogen and CRP | Diagnostic test | CONTROL, JIA cases |
Primary outcome
The fibrinogen to albumin ratio
Time frame: 3 months
measurement of serum fibrinogen and albumin
The CRP to albumin ratio
Time frame: 3 MONTHS
measurement of serum CRP and albumin
Correlation of fibrinogen to albumin and CRP to albumin ratios on one side with disease activity on the other side
Time frame: 3 MONTHS
correlation of these ratios with JADAS27
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
Related trials for Juvenile Idiopathic Arthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, 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?
The sponsor lists 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fibrinogen to albumin ratio (time frame: 3 months). The study lists 3 primary outcomes in all. 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 6 Oct 2023.