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IRCT20190630044054N1 IRCT 2020-02-25 Persisgen Par Co. Clinical trial of PerkinRA in comparison with Kineret® (manufactured by SOBi) 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. 2020-05-19 anticipated 72 Complete https://irct.ir/trial/40646 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization sequences for patients will be made online in sealedenvelope.com. This randomization sequence is consist of quadruple permuted balanced blocks to achieve the target sample size of 72 volunteers which its allocation ratio is 1:1. Each of these sequences will be converted to untitled codes of two letter and one number. and then four letters (corresponding to initial alphabets of volunteer’s name and family name ) are added to these codes. CRO is in charge of creating random codes. Concealment: Randomization sequences will be made before starting the study and unique codes which be assigned to each patient and his pack. So the sequences will be stay covered from everyone. Packages contain 28 syringes and there will be codes and research label based on sequences on packages and syringes , Blinding description: This study is designed as a double blind one. all actions due to research labeling, including: take off labels, relabel as standard research labeling will be done in AryoGen. Date and exact place of this procedure will be announced officially to regulatory and supervision team. product which is produced by Persisgen Par is designed exactly the same as originator. all syringes which are used in this study will be packed in invisible 7 syringes box. all packed will be sealed by single use label. randomization codes will be assigned on this packs. based on this scenario patient and clinical outcome assessor will be blind to patient allocation to treatment groups and the data will be sent to data management team as coded. 3 Systematic Juvenile Idiopathic Arthritis. 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 visits) and by patients or his/her parents daily. site of injection should be rotated daily to reduce the risk of pain and hematoma. also the site of injection should be cooled by ice to reduce the pain. Intervention 2: Control group: 100mg/ 0.67ml prefilled syringe (manufactured by SOBi), subcutaneous injection, dose 1-2 mg/kg to maximum 100 mg, which is injected by the nurses (in all visits) and by patients or his/her parents daily. site of injection should be rotate daily to reduce the risk of pain and hematoma. also the site of injection should be cooled by ice to reduce the pain. No - There is not a plan to make this available Justification or reason for not sharing IPD is Clinical trial data is confidential and dedicated to the company.
public Dr. Seyyed Hamed Hosseini
Unit 23, 4th Floor, NO. 1547, Tehran University of Medical Science Research Center, North Kargar st., Before Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1417993337 +98 21 8896 3546 ctc@tums.ac.ir Trial Research Company scientific Dr. Reza Shiarei
Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran
Tehran Iran (Islamic Republic of) 15514- 15468 +98 21 2641 1681 shiareza@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 1 year 16 years Both 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 M08.0 Unspecified juvenile rheumatoid arthritis Treatment - Drugs Treatment - Drugs 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 visits) and by patients or his/her parents daily. site of injection should be rotated daily to reduce the risk of pain and hematoma. also the site of injection should be cooled by ice to reduce the pain. Control group: 100mg/ 0.67ml prefilled syringe (manufactured by SOBi), subcutaneous injection, dose 1-2 mg/kg to maximum 100 mg, which is injected by the nurses (in all visits) and by patients or his/her parents daily. site of injection should be rotate daily to reduce the risk of pain and hematoma. also the site of injection should be cooled by ice to reduce the pain. 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. 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. Persisgen Par Co. Approved 2020-02-09 Shahid Beheshti University of Medical Science Research and technology deputy, Building no. 2, Shahid Beheshti University of Medical Science, Evin Tehran Tehran Iran (Islamic Republic of) Approved 2020-03-01 Deputy of research and technology of Tehran university of medical sciences Keshavarz Blv, Qods street, University Central organization, sixth floor Tehran Tehran Iran (Islamic Republic of)