Interleukin 33 in Juvenile Idiopathic Arthritis Patients

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Diagnostic test: interleukin 33

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

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Qalubiya
    • Banhā, Qalubiya, Egypt, 13518
      • Benha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: interleukin 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; Other Names: IL-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.	Diagnostic test: interleukin 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; Other Names: IL-33

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
27 active joints count	active arthritis, defined as joint swelling or limitation of movement accompanied by pain and tenderness, assessed in 27 joints	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	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	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	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	through study completion, an average of 4 months
C reactive protein (CRP)	CRP measured in mg/L using nephlometry	through study completion, an average of 4 months
Serum ferritin level	Serum ferritin level measured in ng/mL using elisa	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)	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)	through study completion, an average of 4 months
rheumatoid factor	rheumatoid factor measured in U/ml using latex agglutination test	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	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.	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	through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 8, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Juvenile Idiopathic Arthritis; Interleukin 33
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: Benha University (Benha university)