Skip to main content
OpenTrials
Completed

NCT Number: NCT03835624

Interleukin 33 in Juvenile Idiopathic Arthritis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13518, Egypt

About this study

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

  • complete blood count.
  • Erythrocyte sedmentation rate.
  • C-reactive protein .
  • Liver enzymes: ALT and AST.
  • Rheumatoid factor.
  • Antinuclear antibody (ANA).
  • serum ferritin
  • serum and synovial fluid Interleukin 33 by ELISA and its relative expression in peripheral blood mononuclear cells by PCR

E) Musculoskeletal Ultrasound examination

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Other autoimmune diseases Vasculitis- SLE- Rheumatic fever- Dermatomyositis- Polymyositis- Enteropathic arthritis- Behcet disease- Sjogren-Scleroderma- Mixed connective diseases
  • Infectious disease or septic arthritis.
  • Metabolic diseases.
  • Endocrine diseases.
  • Neuropathic diseases.
  • Heritable bone disease.
  • Neoplastic diseases including leukemia.
  • Sarcoidosis.
  • Familial Mediterranean fever. 2-Exclusion of children with diseases that affect serum level of IL 33 as:

<!-- -->

  • Inflammatory diseases of airway e.g asthma
  • Inflammatory bowel disease
  • Systemic lupus erythmatosus
  • Inflammatory skin disease e.g :atopic dermatitis
  • Cancer

Treatment and study plan

interleukin 33

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

Other names: IL-33

Primary outcomes

  1. 27 active joints count

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: through study completion, an average of 4 months

    CRP measured in mg/L using nephlometry

  7. Serum ferritin level

    Time frame: through study completion, an average of 4 months

    Serum ferritin level measured in ng/mL using elisa

  8. grey scale 10 joint score

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.