Clinical trial of PerkinRA in comparison with Kineret® (manufactured by SOBi)

Phase 3

Recruiting

• Conditions: Systematic Juvenile Idiopathic Arthritis.; Unspecified juvenile rheumatoid arthritis; M08.0

• Registration Number: IRCT20190630044054N1
• Lead Sponsor: Persisgen Par Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.