Juvenile Idiopathic Arthritis
Conditions
Keywords
Juvenile Idiopathic Arthritis, Interleukin 33
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
Interventions
DIAGNOSTIC_TESTinterleukin 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
Sponsors
Benha University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| parent/patient global assessment of well-being scale | 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) | through study completion, an average of 4 months | ESR measured in mm/1st hour by westergren method |
| 27 active joints count | 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 | 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 |
| The 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) | 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) | through study completion, an average of 4 months | CRP measured in mg/L using nephlometry |
| Serum ferritin level | through study completion, an average of 4 months | Serum ferritin level measured in ng/mL using elisa |
| grey scale 10 joint score | 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 | 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 | 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) | 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 | 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) | 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 |
Countries
Egypt
Outcome results
None listed