Clinical trial NCT03835624: Interleukin 33 in Juvenile Idiopathic Arthritis Patients
Official title: Interleukin 33 in Juvenile Idiopathic Arthritis Patients :Relation to Disease State and Muscloskeletal Ultrasound Findings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Keywords: Juvenile Idiopathic Arthritis
Interleukin 33
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 120
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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

B) Full clinical examination

C) Clinical assessment of disease activity

D) Laboratory Investigations:

All subjects will be investigated by

1. complete blood count.
2. Erythrocyte sedmentation rate.
3. C-reactive protein .
4. Liver enzymes: ALT and AST.
5. Rheumatoid factor.
6. Antinuclear antibody (ANA).
7. serum ferritin
8. serum and synovial fluid Interleukin 33 by ELISA and its relative expression in peripheral blood mononuclear cells by PCR

E) Musculoskeletal Ultrasound examination

Eligibility criteria: Inclusion Criteria:

* Children less than 16 years old diagnosed according to ILAR classification criteria of juvenile idiopathic arthritis

Exclusion Criteria:

* 1-Exclusion other causes of arthritis in children as:

  1. Other autoimmune diseases Vasculitis- SLE- Rheumatic fever- Dermatomyositis- Polymyositis- Enteropathic arthritis- Behcet disease- Sjogren-Scleroderma- Mixed connective diseases
  2. Infectious disease or septic arthritis.
  3. Metabolic diseases.
  4. Endocrine diseases.
  5. Neuropathic diseases.
  6. Heritable bone disease.
  7. Neoplastic diseases including leukemia.
  8. Sarcoidosis.
  9. Familial Mediterranean fever. 2-Exclusion of children with diseases that affect serum level of IL 33 as:

  <!-- -->

  1. Inflammatory diseases of airway e.g asthma
  2. Inflammatory bowel disease
  3. Systemic lupus erythmatosus
  4. Inflammatory skin disease e.g :atopic dermatitis
  5. Cancer

Primary outcomes:
measure: 27 active joints count
timeFrame: through study completion, an average of 4 months
measure: physician's global assessment of disease activity scale
timeFrame: through study completion, an average of 4 months.
measure: parent/patient global assessment of well-being scale
timeFrame: through study completion, an average of 4 months.isit to measure IL33
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: through study completion, an average of 4 months
measure: The 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
timeFrame: through study completion, an average of 4 months
measure: C reactive protein (CRP)
timeFrame: through study completion, an average of 4 months
measure: Serum ferritin level
timeFrame: through study completion, an average of 4 months
measure: grey scale 10 joint score
timeFrame: through study completion, an average of 4 months
measure: power Doppler 10 joint score
timeFrame: through study completion, an average of 4 months
measure: rheumatoid factor
timeFrame: through study completion, an average of 4 months
measure: disease activity for systemic arthritis with active systemic features (and without active arthritis)
timeFrame: through study completion, an average of 4 months
measure: The Juvenile Arthritis Multidimensional Assessment Report
timeFrame: through study completion, an average of 4 months
measure: disease activity for systemic arthritis with active arthritis (and without active systemic features)
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital
state: Qalubiya
Study officials:
affiliation: Benha university- Qaluibya- Egypt
name: Waleed Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: