Interleukin 33 in Juvenile Idiopathic Arthritis Patients

Completed

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Diagnostic Test: interleukin 33

• Registration Number: NCT03835624
• Lead Sponsor: Benha University

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

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Study Start: 2019-02-12
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-08
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	interleukin 33	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.
juvenile idiopathic arthritis	interleukin 33	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

Primary Outcome Measures

Name	Time	Method
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
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
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)
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
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
Erythrocyte sedimentation rate (ESR)	through study completion, an average of 4 months	ESR measured in mm/1st hour by westergren method
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 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
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
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)
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.

Trial Locations

Locations (1)

Benha University Hospital; 🇪🇬 Banhā, Qalubiya, Egypt