Protocol summary
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Study aim
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Evaluate the efficacy and safety of PerkinRA ( manufactured by PersisgenPar CO) in comparison with Kineret (Reference product, manufactured by SOBi )
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Design
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A Phase III, Randomized,Two armed, Parallel, Double blinded (volunteers and analysis team), Active controlled Non-inferiority.
Target sample size : 72 volunteers.
In two groups candidate and reference product
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Settings and conduct
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This study will be performed on children with systemic JIA based on the ILAR 2018 criteria that will be treated in the Rheumatology Department of Mofid Hospital, Children's Medical Center, Afzalipour hospital, Namazi hospital and 17 shahrivar hosptial between 1398 and 1400.
Methods are standardized absolutely and discrepancies in evaluation criteria and study design are reduced by researcher's sessions, pre-study training for staff and Exact monitoring during the study .
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Participants/Inclusion and exclusion criteria
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Age under 16 years, weight at least 10 kg, Systemic Juvenile Arthritis subject based on ILAR criteria, obtaining written informed consent from patients
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Intervention groups
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Two groups: First group administer candidate drug (PerkinRA) subcutaneously (1-2 mg/kg) and second group administer Kineret (reference product) subcutaneously (1-2 mg/kg)
For both groups the maximum dose is 100 mg daily.
In both groups drugs will be injected at the first of study, after 1, 2, 4, 8, 12, 16, 20, 24 weeks of first injection.
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Main outcome variables
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The therapeutic response is based on ACR30 which includes:
1) Number of swollen joints (28 joints)
2) Number of painful joints (28 joints)
3) Overall assessment of the severity of the disease by physician
4) Overall assessment of the severity of the disease by patient
5) Physical ability of the patient based on CHAQ criteria
6) Levels of ESR or CRP (laboratory markers)
General information
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Reason for update
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Increasing the number of patient enrollment centers
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190630044054N1
Registration date:
2020-02-25, 1398/12/06
Registration timing:
prospective
Last update:
2020-12-16, 1399/09/26
Update count:
1
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Registration date
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2020-02-25, 1398/12/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-19, 1399/02/30
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Expected recruitment end date
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2021-09-23, 1400/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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Clinical trial of PerkinRA in comparison with Kineret® (manufactured by SOBi)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 1 year old to 16 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 .
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-09, 1398/11/20
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Ethics committee reference number
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IR.SBMU.REC.1398.161
2
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Ethics committee
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Approval date
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2020-03-01, 1398/12/11
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.992
Health conditions studied
1
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Description of health condition studied
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Systematic Juvenile Idiopathic Arthritis
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ICD-10 code
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M08.0
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ICD-10 code description
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Unspecified juvenile rheumatoid arthritis
Primary outcomes
1
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Description
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Medical response based on American College of Rheumatology (ACR)
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Timepoint
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At the first of study, َAfter 12 weeks of first visit, After 24 weeks of first visit
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Method of measurement
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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 outcomes
1
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Description
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ACR 30 response
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Timepoint
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Week-4 to -8, 12, 24
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Method of measurement
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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
2
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Description
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Treatment response in overall assessment of disease ratio
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Timepoint
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Week-4 to -8, 12, 24
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Method of measurement
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Based on patient assessment
3
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Description
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Decrease in inflamed joints ratio
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Timepoint
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Week-4 to -8, 12, 24
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Method of measurement
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Based on physician examination
4
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Description
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Decrease in number of joints with movement restriction ratio
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Timepoint
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Week-4 to -8, 12, 24
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Method of measurement
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Based on physician examination
5
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Description
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Response to function improvement ratio
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Timepoint
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Week-4 to -8, 12, 24
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Method of measurement
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Based on standardized and validated CHAQ Persian questionnaire
6
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Description
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Decrease in CRP and ESR level
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Timepoint
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Week-4 to -8, 12, 24
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Method of measurement
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Laboratory test
7
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Description
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ADE
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Timepoint
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Day 0, weeks 1, 2, 4, 8,12, 16, 20, 24
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Method of measurement
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Questionnaire
8
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Description
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Changes in findings related to physical examination
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Timepoint
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Screening visit, day 0, and weeks 1, 2, 4, 8, 12, 16, 20, 24
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Method of measurement
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Questionnaire
9
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Description
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Vital Sign Record
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Timepoint
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Screening visit, day 0, and weeks 1, 2, 4, 8, 12, 16, 20, 24
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Method of measurement
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Body Temperature, Respiratory Rate, Blood Pressure, Heart Rate
10
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Description
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Systemic Immunological assessment
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Timepoint
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Screening Visit, Week 12, 24
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Method of measurement
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Clinical Lab Tests (LFT, Kidney Function, CBC and Biochemical Tests)
11
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Description
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Immunogenicity
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Timepoint
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Day 0, Weeks 12, 24
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Method of measurement
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Antibody against Drug evaluation
12
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Description
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The ratio of respondents to treatment in the overall activity rate of the disease
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Timepoint
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Screening visit, week 12 and 24
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Method of measurement
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Based on patient assessment
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Persisgen Par Co.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Clinical trial data is confidential and dedicated to the company.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available