IRCT20190630044054N1RecruitingPhase 3
A Phase III, randomized, two armed, parallel, double blinded, active controlled non-inferiority to evaluate the efficacy and safety of PerkinRA (manufactured by Persisgen Par CO) in comparison with Kineret (Reference product, manufactured by SOBi ) in systemic Juvenile idiopathic arthritis.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Persisgen Par Co.
- Enrollment
- 72
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 1 year to 16 years (—)
- Sex
- All
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
Investigators
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