Interleukin 33 in Juvenile Idiopathic Arthritis Patients

• Sponsor: Benha University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03835624
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 13

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis	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

1. Full clinical examination

2. 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

1. Musculoskeletal Ultrasound examination

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Interleukin 33 in Juvenile Idiopathic Arthritis Patients :Relation to Disease State and Muscloskeletal Ultrasound Findings
• Actual Study Start Date: Feb 12, 2019
• Actual Primary Completion Date: Nov 20, 2019
• Actual Study Completion Date: Nov 20, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. Erythrocyte sedimentation rate (ESR) [through study completion, an average of 4 months]

   ESR measured in mm/1st hour by westergren method

5. 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

6. C reactive protein (CRP) [through study completion, an average of 4 months]

   CRP measured in mg/L using nephlometry

7. Serum ferritin level [through study completion, an average of 4 months]

   Serum ferritin level measured in ng/mL using elisa

8. 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)

9. 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)

10. rheumatoid factor [through study completion, an average of 4 months]

    rheumatoid factor measured in U/ml using latex agglutination test

11. 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

12. 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.

13. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 16 Years
• Sexes Eligible for Study: All
• Accepts 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:

10. Inflammatory diseases of airway e.g asthma

11. Inflammatory bowel disease

12. Systemic lupus erythmatosus

13. Inflammatory skin disease e.g :atopic dermatitis

14. Cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benha University Hospital	Banhā	Qalubiya	Egypt	13518

Sponsors and Collaborators

• Benha University

Investigators

• Principal Investigator: Waleed Hassan, MD, Benha university- Qaluibya- Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Waleed Ahmed Salaheldeen Hassan, Assistant professor, Benha University
• ClinicalTrials.gov Identifier: NCT03835624
• Other Study ID Numbers: Benha University
• First Posted: Feb 8, 2019
• Last Update Posted: Dec 11, 2019
• Last Verified: Dec 1, 2019

• Keywords provided by Waleed Ahmed Salaheldeen Hassan, Assistant professor, Benha University: Juvenile Idiopathic Arthritis; Interleukin 33
• Additional relevant MeSH terms: Arthritis; Arthritis, Juvenile

Study Results

No Results Posted as of Dec 11, 2019