Interleukin 33 in Juvenile Idiopathic Arthritis Patients

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Interleukin 33 in Juvenile Idiopathic Arthritis Patients :Relation to Disease State and Muscloskeletal Ultrasound Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835624
• Other study ID #: Benha University
• Status: Completed
• Start date: February 12, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: December 2019
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha University Hospital	Banha	Qalubiya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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
Primary	Erythrocyte sedimentation rate (ESR)	ESR measured in mm/1st hour by westergren method	through study completion, an average of 4 months
Primary	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
Primary	C reactive protein (CRP)	CRP measured in mg/L using nephlometry	through study completion, an average of 4 months
Primary	Serum ferritin level	Serum ferritin level measured in ng/mL using elisa	through study completion, an average of 4 months
Primary	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
Primary	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
Primary	rheumatoid factor	rheumatoid factor measured in U/ml using latex agglutination test	through study completion, an average of 4 months
Primary	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
Primary	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
Primary	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