Interleukin 33 in Juvenile Idiopathic Arthritis Patients

NCT ID: NCT03835624

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-12

Study Completion Date

2019-11-20

Brief Summary

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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

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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

Conditions

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Juvenile Idiopathic Arthritis

Keywords

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Juvenile Idiopathic Arthritis Interleukin 33

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

interleukin 33

Intervention Type DIAGNOSTIC_TEST

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

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.

interleukin 33

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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IL-33

Eligibility Criteria

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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:

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Waleed Ahmed Salaheldeen Hassan

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Benha university- Qaluibya- Egypt

Locations

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Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Benha University

Identifier Type: -

Identifier Source: org_study_id