Systematic Juvenile Idiopathic Arthritis. Unspecified juvenile rheumatoid arthritis
Conditions
Interventions
Intervention 1: Intervention group: 100mg/ 0.67ml prefilled syringe (manufactured by Persisgen Par), subcutaneous injection, dose 1-2 mg/kg to maximum 100 mg, which is injected by the nurses (in all v
Sponsors
Persisgen Par Co.
Eligibility
Sex/Gender
All
Age
1 Years to 16 Years
Inclusion criteria
Inclusion criteria: Under the age of 16 Weight at least 10 kg Systemic Juvenile Arthritis subject based on ILAR criteria (2018 version) Obtaining informed consent from patients
Exclusion criteria
Exclusion criteria: Positive PDD Test Patients with active hepatitis B and C Patients with antibody titre against peripheral antigen of hepatitis B OR hepatitis C History of HIV infection Patients with history of thrombocytopenia or leukopenia Hemoglobin level less than 7.5 g/dl Patients with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) 2 times higher than the normal range. Patients with active infection (based on relevant tests and urine culture) so that been treated with injectable antibiotics within 8 weeks before screening, or with oral antibiotics within 2 weeks before screening. Patients with a history of malignancy during the 5 years before screening based on sinuses radiography and sampling If the patient is receiving corticosteroids and dose change the during 1 week before study Administration of Anakinra, Canakinumab or any Interleukin 1 inhibitors drugs. Administration of live-attenuated vaccines within 2 weeks before study or have plan for it during the study. History of allergic reaction to biologic agents or any constituents of formulation. Patients with Kawasaki based on echocardiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical response based on American College of Rheumatology (ACR). Timepoint: At the first of study, ?After 12 weeks of first visit, After 24 weeks of first visit. Method of measurement: Percentage of disease's progress based on doctor's opinion (score 0-10), general evaluation of patients with visual chart (score 0-10), Performance Ability Based on Standardized and Validated Child Health Assessment Questionnaire (CHAQ), Number of inflamed joints based on doctor's examination, Number of joints with limited movement based on physician examination, ESR and CRP reduction. | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR 30 response. Timepoint: Week-4 to -8, 12, 24. Method of measurement: ACR 30 Questionnaire including Number of tender joints, Number of swollen joints, Patient assessment of pain, Patient’s global assessment of disease activity, Physician’s global assessment of disease activity, HAQ-DI, ESR, CRP.;Treatment response in overall assessment of disease ratio. Timepoint: Week-4 to -8, 12, 24. Method of measurement: Based on patient assessment.;Decrease in inflamed joints ratio. Timepoint: Week-4 to -8, 12, 24. Method of measurement: Based on physician examination.;Decrease in number of joints with movement restriction ratio. Timepoint: Week-4 to -8, 12, 24. Method of measurement: Based on physician examination.;Response to function improvement ratio. Timepoint: Week-4 to -8, 12, 24. Method of measurement: Based on standardized and validated CHAQ Persian questionnaire.;Decrease in CRP and ESR level. Timepoint: Week-4 to -8, 12, 24. Method of measurement: Laboratory test.;ADE. Timepoint: Day 0, weeks 1, 2, 4, 8,12, 16, 20, 24. Method of measurement: Questionnaire.;Changes in findings related to physical examination. Timepoint: Screening visit, day 0, and weeks 1, 2, 4, 8, 12, 16, 20, 24. Method of measurement: Questionnaire.;Vital Sign Record. Timepoint: Screening visit, day 0, and weeks 1, 2, 4, 8, 12, 16, 20, 24. Method of measurement: Body Temperature, Respiratory Rate, Blood Pressure, Heart Rate.;Systemic Immunological assessment. Timepoint: Screening Visit, Week 12, 24. Method of measurement: Clinical Lab Tests (LFT, Kidney Function, CBC and Biochemical Tests).;Immunogenicity. Timepoint: Day 0, Weeks 12, 24. Method of measurement: Antibody against Drug evaluation.;The ratio of respondents to treatment in the overall activity rate of the disease. Timepoint: Screening visit, week 12 and 24. Method of measurement: Based on patient assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Seyyed Hamed Hosseini
Trial Research Company
Outcome results
None listed