Juvenile Idiopathic ArthritisNCT03835624
Interleukin 33 in Juvenile Idiopathic Arthritis Patients
An observational study of Juvenile Idiopathic Arthritis, run by Benha University at 1 site in Egypt.
Trial summary
The aim of this study is to measure serum and synovial fluid levels of IL 33 and its relative mRNA expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (JIA) patients and to correlate it with the clinical and laboratory characteristics, disease activity and musculoskeletal ultrasound… 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?
- interleukin 33
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2019to 20 Nov 2019
- 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: This study will be a case-control study including sixty children with juvenile idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and and 60 apparently healthy children as controls. They will be classified into: * Group (I) study group:60 cases of children with juvenile idiopathic arthritis. * Group (II) Control group:60 of apparently healthy children matched for age and sex.
Who may be able to join
- Children less than 16 years old diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis
Who cannot join
- 1-Exclusion other causes of arthritis in children as:
- Other autoimmune diseases Vasculitis- SLE- Rheumatic fever- Dermatomyositis- Polymyositis- Enteropathic arthritis- Behcet disease- Sjogren-Scleroderma- Mixed connective diseases
- Infectious disease or septic arthritis.
- Metabolic diseases.
- Endocrine diseases.
- Neuropathic diseases.
Show all 16Show fewer
- Heritable bone disease.
- Neoplastic diseases including leukemia.
- Sarcoidosis.
- Familial Mediterranean fever. 2-Exclusion of children with diseases that affect serum level of IL 33 as:
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- Inflammatory diseases of airway e.g asthma
- Inflammatory bowel disease
- Systemic lupus erythmatosus
- Inflammatory skin disease e.g :atopic dermatitis
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interleukin 33 in Juvenile Idiopathic Arthritis Patients :Relation to Disease State and Muscloskeletal Ultrasound Findings
The aim of this study is to measure serum and synovial fluid levels of IL 33 and its relative mRNA expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (JIA) patients and to correlate it with the clinical and laboratory characteristics, disease activity and musculoskeletal ultrasound findings.
Read the detailed description
SUBJECTS AND METHODS
Subjects:This study will be a case-control study including sixty children with juvenile idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and Benha children hospital and thirty apparently healthy children as controls. They will be classified into:
- Group (I) study group:60 cases of children with juvenile idiopathic arthritis.
- Group (II) Control group:60 of apparently healthy children matched for age and sex
A)Full history taking
- Full clinical examination
- Clinical assessment of disease activity
- Laboratory Investigations:
All subjects will be investigated by
- complete blood count.
- Erythrocyte sedmentation rate.
- C-reactive protein .
- Liver enzymes: ALT and AST.
- Rheumatoid factor.
- Antinuclear antibody (ANA).
- serum ferritin
- serum and synovial fluid Interleukin 33 by ELISA and its relative expression in peripheral blood mononuclear cells by PCR
- Musculoskeletal Ultrasound examination
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- interleukin 33
- Keywords
- Juvenile Idiopathic Arthritis, Interleukin 33
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin 33Diagnostic test
Also called IL-33
serum and synovial fluid samples will be obtained from patients and serum samples from controls to measure interleukin 33 and its relative mRNA expression in peripheral blood mononuclear cells by PCR
| Study group | Role | What they receive |
|---|---|---|
| juvenile idiopathic arthritis | about 60 cases of children with juvenile idiopathic arthritis diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis will be recruited from pediatric rheumatology clinic of Benha university hospital serum interleukin 33 and its relative expression in peripheral blood mononuclear cells (PBMNCs) will be measured in their blood samples also IL-33 will be measured in synovial fluid samples Receives: Diagnostic Test: interleukin 33 | |
| control group | about 60 apparently healthy children with comparable age and sex to the patients.
serum interleukin 33 and its relative expression in PBMNCs will be measured in their bloodsamples. Receives: Diagnostic Test: interleukin 33 |
What is being measured
The primary outcome is the main question the study is designed to answer.
27 active joints count
active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints
Measured: through study completion, an average of 4 months
physician's global assessment of disease activity scale
physician's global assessment of disease activity on a 0- 10 cm visual analogue scale (VAS). Higher value indicates worse outcome
Measured: through study completion, an average of 4 months.
parent/patient global assessment of well-being scale
parent/patient global assessment of well-being on a 0-10 cm visual analogue scale .Higher value indicates worse outcome
Measured: through study completion, an average of 4 months.isit to measure IL33
Erythrocyte sedimentation rate (ESR)
ESR measured in mm/1st hour by westergren method
Measured: through study completion, an average of 4 months
The 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
The JADAS-27 (range 0-57) was computed by summing the scores of four core-set criteria [3]: physician's global assessment of disease activity (PGA) on a 10 cm visual analogue scale (VAS); parent/patient global assessment of well-being on a 10 cm VAS [7]; active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints; and ESR (mm/h) normalized to a 0-10 scale, using the formula ESR - 20/10, whereby, before the calculation, ESR values <20 mm/h were converted to 0 and ESR values >120 mm/h were converted to 120. A higher JADAS-27 indicates higher disease activity and a lower JADAS-27 indicates lower disease activity
Measured: through study completion, an average of 4 months
C reactive protein (CRP)
CRP measured in mg/L using nephlometry
Measured: through study completion, an average of 4 months
Serum ferritin level
Serum ferritin level measured in ng/mL using elisa
Measured: through study completion, an average of 4 months
grey scale 10 joint score
grey scale musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)
Measured: through study completion, an average of 4 months
power Doppler 10 joint score
power Doppler musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)
Measured: through study completion, an average of 4 months
rheumatoid factor
rheumatoid factor measured in U/ml using latex agglutination test
Measured: through study completion, an average of 4 months
disease activity for systemic arthritis with active systemic features (and without active arthritis)
DISEASE ACTIVITY LEVELS (2 levels) Active fever AND physician global assessment of overall disease activity 7 of 10 Active fever AND systemic features of high disease activity (e.g., significant serositis) that result in physician global assessment of overall disease activity 7 of 10
Measured: through study completion, an average of 4 months
The Juvenile Arthritis Multidimensional Assessment Report
The JAMAR is a questionnaire includes the following 15 sections:
Assessment of physical function (PF) using 15-items with score 0-45. Higher scores indicating higher degree of disability 2. 21-numbered circle Visual Analogue Scale (VAS) for pain 3. Assessment of the presence of joint pain or swelling.4.Assessment of morning stiffness 5. extra-articular symptoms (fever and rash) 6.disease activity on a 21-circle VAS. 7.disease status. 8. course. 9.medications . 10. side effects. 11.difficulties with medication 12. school/university/work problems. 13. HRQoL 14.patient's overall well-being on a 21-numbered circle VAS. 15. satisfaction with outcome.
Measured: through study completion, an average of 4 months
disease activity for systemic arthritis with active arthritis (and without active systemic features)
Low disease activity (must satisfy all) 4 or fewer active joints, ESR or CRP level normal PGA of disease activity less than4 of, 10 PAGA of well-being 2 of 10 Moderate disease activity (does not satisfy criteria for low or high disease activity) High disease activity (must satisfy at least 3) 8 or more active joints,ESR or CRP level greater than twice upper limit of normal, PGA of disease activity 7 of 10, PAGA of well-being 5 of 10
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start12 Feb 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
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 Benha 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ahmed Salaheldeen Hassan, Benha University
- Investigators
- Waleed Hassan, MD, Principal investigator, Benha university- Qaluibya- Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835624
- Sponsor's protocol ID
- Benha University
- Status last verified
- Dec 2019
- First submitted
- 7 Feb 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin 33 in Juvenile Idiopathic Arthritis Patients :Relation to Disease State and Muscloskeletal Ultrasound Findings
- ClinicalTrials.gov ID
- NCT03835624
- Acronym / sponsor ID
- Benha University
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Juvenile Idiopathic Arthritis, Interleukin 33
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 8 Feb 2019 (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 aim of this study is to measure serum and synovial fluid levels of IL 33 and its relative mRNA expression in peripheral blood mononuclear cells in juvenile idiopathic arthritis (JIA) patients and to correlate it with the clinical and laboratory characteristics, disease activity and musculoskeletal ultrasound findings.
Detailed description
SUBJECTS AND METHODS
Subjects:This study will be a case-control study including sixty children with juvenile idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and Benha children hospital and thirty apparently healthy children as controls. They will be classified into:
- Group (I) study group:60 cases of children with juvenile idiopathic arthritis.
- Group (II) Control group:60 of apparently healthy children matched for age and sex
A)Full history taking
- Full clinical examination
- Clinical assessment of disease activity
- Laboratory Investigations:
All subjects will be investigated by
- complete blood count.
- Erythrocyte sedmentation rate.
- C-reactive protein .
- Liver enzymes: ALT and AST.
- Rheumatoid factor.
- Antinuclear antibody (ANA).
- serum ferritin
- serum and synovial fluid Interleukin 33 by ELISA and its relative expression in peripheral blood mononuclear cells by PCR
- Musculoskeletal Ultrasound examination
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| juvenile idiopathic arthritis | – | Diagnostic Test: interleukin 33about 60 cases of children with juvenile idiopathic arthritis diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis will be recruited from pediatric rheumatology clinic of Benha university hospital serum interleukin 33 and its relative expression in peripheral blood mononuclear cells (PBMNCs) will be measured in their blood samples also IL-33 will be measured in synovial fluid samples |
| control group | – | Diagnostic Test: interleukin 33about 60 apparently healthy children with comparable age and sex to the patients. serum interleukin 33 and its relative expression in PBMNCs will be measured in their bloodsamples. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will be a case-control study including sixty children with juvenile idiopathic arthritis attending pediatric rheumatology clinic of Benha University Hospital and and 60 apparently healthy children as controls. They will be classified into: * Group (I) study group:60 cases of children with juvenile idiopathic arthritis. * Group (II) Control group:60 of apparently healthy children matched for age and sex.
Key inclusion criteria (1 listed)
- Children less than 16 years old diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis
Key exclusion criteria (16 listed)
- 1-Exclusion other causes of arthritis in children as:
- <!-- -->
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 |
|---|---|---|
| interleukin 33Also: IL-33serum and synovial fluid samples will be obtained from patients and serum samples from controls to measure interleukin 33 and its relative mRNA expression in peripheral blood mononuclear cells by PCR | Diagnostic test | control group, juvenile idiopathic arthritis |
Primary outcome
27 active joints count
Time frame: through study completion, an average of 4 months
active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints
physician's global assessment of disease activity scale
Time frame: through study completion, an average of 4 months.
physician's global assessment of disease activity on a 0- 10 cm visual analogue scale (VAS). Higher value indicates worse outcome
parent/patient global assessment of well-being scale
Time frame: through study completion, an average of 4 months.isit to measure IL33
parent/patient global assessment of well-being on a 0-10 cm visual analogue scale .Higher value indicates worse outcome
Erythrocyte sedimentation rate (ESR)
Time frame: through study completion, an average of 4 months
ESR measured in mm/1st hour by westergren method
The 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
Time frame: through study completion, an average of 4 months
The JADAS-27 (range 0-57) was computed by summing the scores of four core-set criteria [3]: physician's global assessment of disease activity (PGA) on a 10 cm visual analogue scale (VAS); parent/patient global assessment of well-being on a 10 cm VAS [7]; active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints; and ESR (mm/h) normalized to a 0-10 scale, using the formula ESR - 20/10, whereby, before the calculation, ESR values <20 mm/h were converted to 0 and ESR values >120 mm/h were converted to 120. A higher JADAS-27 indicates higher disease activity and a lower JADAS-27 indicates lower disease activity
C reactive protein (CRP)
Time frame: through study completion, an average of 4 months
CRP measured in mg/L using nephlometry
Serum ferritin level
Time frame: through study completion, an average of 4 months
Serum ferritin level measured in ng/mL using elisa
grey scale 10 joint score
Time frame: through study completion, an average of 4 months
grey scale musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)
power Doppler 10 joint score
Time frame: through study completion, an average of 4 months
power Doppler musculoskeletal ultrasound including 10-joints (bilateral knee, ankle, wrist, elbow and the 2nd metacarpophalangeal (MCP) joints)
rheumatoid factor
Time frame: through study completion, an average of 4 months
rheumatoid factor measured in U/ml using latex agglutination test
disease activity for systemic arthritis with active systemic features (and without active arthritis)
Time frame: through study completion, an average of 4 months
DISEASE ACTIVITY LEVELS (2 levels) Active fever AND physician global assessment of overall disease activity 7 of 10 Active fever AND systemic features of high disease activity (e.g., significant serositis) that result in physician global assessment of overall disease activity 7 of 10
The Juvenile Arthritis Multidimensional Assessment Report
Time frame: through study completion, an average of 4 months
The JAMAR is a questionnaire includes the following 15 sections: Assessment of physical function (PF) using 15-items with score 0-45. Higher scores indicating higher degree of disability 2. 21-numbered circle Visual Analogue Scale (VAS) for pain 3. Assessment of the presence of joint pain or swelling.4.Assessment of morning stiffness 5. extra-articular symptoms (fever and rash) 6.disease activity on a 21-circle VAS. 7.disease status. 8. course. 9.medications . 10. side effects. 11.difficulties with medication 12. school/university/work problems. 13. HRQoL 14.patient's overall well-being on a 21-numbered circle VAS. 15. satisfaction with outcome.
disease activity for systemic arthritis with active arthritis (and without active systemic features)
Time frame: through study completion, an average of 4 months
Low disease activity (must satisfy all) 4 or fewer active joints, ESR or CRP level normal PGA of disease activity less than4 of, 10 PAGA of well-being 2 of 10 Moderate disease activity (does not satisfy criteria for low or high disease activity) High disease activity (must satisfy at least 3) 8 or more active joints,ESR or CRP level greater than twice upper limit of normal, PGA of disease activity 7 of 10, PAGA of well-being 5 of 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
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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. This study is not recruiting at the moment.
Waleed Hassan, MD principal investigator
Benha university- Qaluibya- Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by Benha University at 1 site in Egypt.
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 16 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: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
27 active joints count (time frame: through study completion, an average of 4 months). The study lists 13 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 11 Dec 2019.