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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Protocol summary
evaluate the efficacy of Protection and safety of LEUKINRA ( manufactured by PersisgenPar CO) in comparison with Keniret (Reference product, manufactured by SOBi )
Evaluate the efficacy and safety of PerkinRA ( manufactured by PersisgenPar CO) in comparison with Kineret (Reference product, manufactured by SOBi )
evaluateEvaluate the efficacy of Protection and safety of LEUKINRAPerkinRA ( manufactured by PersisgenPar CO) in comparison with KeniretKineret (Reference product, manufactured by SOBi )
بررسی ویژگی های اثربخشی و ایمنی داروی تولید شده توسط پرسیس ژن پار در مقایسه با Kineret® (محصول مرجع، تولید شده توسط شرکت SOBi)
بررسی ویژگی های اثربخشی و ایمنی پرکینرا داروی تولید شده توسط پرسیس ژن پار در مقایسه با Kineret® (محصول مرجع، تولید شده توسط شرکت SOBi)
بررسی ویژگی های اثربخشی و ایمنی پرکینرا داروی تولید شده توسط پرسیس ژن پار در مقایسه با Kineret® (محصول مرجع، تولید شده توسط شرکت SOBi)
A Phase III, Randomized,Two armed, Parallel, Double blinded (volunteers and analysis team), Active controlled Non-inferiority.
target sample size : 72 volunteers. In two candidate and reference product
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
A Phase III, Randomized,Two armed, Parallel, Double blinded (volunteers and analysis team), Active controlled Non-inferiority. targetTarget sample size : 72 volunteers. In two groups candidate and reference product
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 and Children's Medical Center 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 .
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 .
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 and, 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 .
این مطالعه بر روی کودکان مبتلا به JIA سیستمیک بر اساس کرایتریاهای 2018 ILAR که در بخش روماتولوژی بیمارستان مفید و مرکز طبی کودکان بین سالهای 1398 تا 1400 تحت درمان قرار خواهند گرفت، انجام می شود.
روش ها تا حد امکان کاملا استاندارد شده و اختلافات در معیارهای ارزیابی و طرح مطالعه توسط جلسات محققین، آموزش پیش از شروع مطالعه برای پرسنل و مانیتورینگ دقیق حین مطالعه کاهش می یابد.
این مطالعه بر روی کودکان مبتلا به JIA سیستمیک بر اساس کرایتریاهای 2018 ILAR که در بخش روماتولوژی بیمارستان مفید، مرکز طبی کودکان، بیمارستان افضلی پور، بیمارستان نمازی، بیمارستان کودکان 17 شهریور بین سالهای 1398 تا 1400 تحت درمان قرار خواهند گرفت، انجام می شود.
روش ها تا حد امکان کاملا استاندارد شده و اختلافات در معیارهای ارزیابی و طرح مطالعه توسط جلسات محققین، آموزش پیش از شروع مطالعه برای پرسنل و مانیتورینگ دقیق حین مطالعه کاهش می یابد.
این مطالعه بر روی کودکان مبتلا به JIA سیستمیک بر اساس کرایتریاهای 2018 ILAR که در بخش روماتولوژی بیمارستان مفید و، مرکز طبی کودکان، بیمارستان افضلی پور، بیمارستان نمازی، بیمارستان کودکان 17 شهریور بین سالهای 1398 تا 1400 تحت درمان قرار خواهند گرفت، انجام می شود. روش ها تا حد امکان کاملا استاندارد شده و اختلافات در معیارهای ارزیابی و طرح مطالعه توسط جلسات محققین، آموزش پیش از شروع مطالعه برای پرسنل و مانیتورینگ دقیق حین مطالعه کاهش می یابد.
Under the age of 16, At least 10 kg, Juvenile Arthritis subject based on ILAR criteria, Obtaining written informed consent from patients
Age under 16 years, weight at least 10 kg, Systemic Juvenile Arthritis subject based on ILAR criteria, obtaining written informed consent from patients
Under the age ofAge under 16 years, Atweight at least 10 kg, Systemic Juvenile Arthritis subject based on ILAR criteria, Obtainingobtaining written informed consent from patients
Two groups. First group administrate Candidate drug(LEUKINRA) subcutaneously(1-2 mg/kg) and second group administrate Keniret (Reference product) subcutaneously(1-2 mg/kg)
For both of groups the maximum dose is 100 mg daily.
In both groups products will be injected at the first of study, after 1, 2, 4, 8, 12, 16, 20, 24 weeks of first injection.
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.
Two groups.: First group administrate Candidate drug(LEUKINRAadminister candidate drug (PerkinRA) subcutaneously(1subcutaneously (1-2 mg/kg) and second group administrate Keniretadminister Kineret (Referencereference product) subcutaneously(1subcutaneously (1-2 mg/kg) For both of groups the maximum dose is 100 mg daily. In both groups productsdrugs will be injected at the first of study, after 1, 2, 4, 8, 12, 16, 20, 24 weeks of first injection.
دو گروه که گروه اول داروی کاندید(لوکینرا) را با دوز 1 الی 2 میلی‌گرم برای هر کیلوگرم به صورت زیرپوستی دریافت می‌کنند. و گروه دوم که داروی مرجع(کینرت) را با دوز 1 الی 2 میلی‌گرم برای هر کیلوگرم به صورت زیرپوستی دریافت می‌کنند.
حداکثر دوز در هر دو گروه، روزانه 100 میلی‌گرم است.
در هر دو گروه دارو در روز ورود به مطالعه(0) و هفته‌های 1، 2، 4، 8، 12، 16، 20 و 24 تزریق می‌شود.
دو گروه که گروه اول داروی کاندید(پرکینرا) را با دوز 1 الی 2 میلی‌گرم برای هر کیلوگرم به صورت زیرپوستی دریافت می‌کنند. و گروه دوم که داروی مرجع(کینرت) را با دوز 1 الی 2 میلی‌گرم برای هر کیلوگرم به صورت زیرپوستی دریافت می‌کنند.
حداکثر دوز در هر دو گروه، روزانه 100 میلی‌گرم است.
در هر دو گروه دارو در روز ورود به مطالعه(0) و هفته‌های 1، 2، 4، 8، 12، 16، 20 و 24 تزریق می‌شود.
دو گروه که گروه اول داروی کاندید(لوکینراکاندید(پرکینرا) را با دوز 1 الی 2 میلی‌گرم برای هر کیلوگرم به صورت زیرپوستی دریافت می‌کنند. و گروه دوم که داروی مرجع(کینرت) را با دوز 1 الی 2 میلی‌گرم برای هر کیلوگرم به صورت زیرپوستی دریافت می‌کنند. حداکثر دوز در هر دو گروه، روزانه 100 میلی‌گرم است. در هر دو گروه دارو در روز ورود به مطالعه(0) و هفته‌های 1، 2، 4، 8، 12، 16، 20 و 24 تزریق می‌شود.
The therapeutic response is based on ACR30 which includes:
1) Number of swollen joints
2) Number of painful 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)
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)
The therapeutic response is based on ACR30 which includes: 1) Number of swollen joints (28 joints) 2) Number of painful joints (28 joints) 3) overallOverall assessment of the severity of the disease by physician 4) overallOverall assessment of the severity of the disease by patient 5) physicalPhysical ability of the patient based on CHAQ criteria 6) Levels of ESR or CRP (laboratory markers)
General information
2019-09-23, 1398/07/01
2020-05-19, 1399/02/30
20192020-0905-2319 00:00:00
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Increasing the number of patient enrollment centers
Increasing the number of patient enrollment centers
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افزایش مراکز بیمارگیری
افزایش مراکز بیمارگیری
Clinical Trial of LEUKINRA in comparison with KINERET® (manufactured by SOBi)
Clinical trial of PerkinRA in comparison with Kineret® (manufactured by SOBi)
Clinical Trialtrial of LEUKINRAPerkinRA in comparison with KINERETKineret® (manufactured by SOBi)
مطالعه بالینی داروی LEUKINRA در مقایسه با KINERET® (تولید شرکت SOBi)
مطالعه بالینی داروی PerkinRA در مقایسه با Kineret® (تولید شرکت SOBi)
مطالعه بالینی داروی LEUKINRAPerkinRA در مقایسه با KINERETKineret® (تولید شرکت SOBi)
A Phase III, Randomized,Two armed, Parallel, Double blinded, Active controlled Non-inferiority to evaluate the efficacy of Protection and safety of PERKINRA (manufactured by PersisgenPar CO) in comparison with Keniret (Reference product, manufactured by SOBi ) in Juvenile idiopathic arthritis.
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.
A Phase III, Randomized,Tworandomized, two armed, Parallelparallel, Doubledouble blinded, Activeactive controlled Nonnon-inferiority to evaluate the efficacy of Protection and safety of PERKINRAPerkinRA (manufactured by PersisgenParPersisgen Par CO) in comparison with KeniretKineret (Reference product, manufactured by SOBi ) in systemic Juvenile idiopathic arthritis.
مطالعه بالینی فاز 3 تصادفی سازی شده، دو بازویی، موازی، دو سوکور، کنترل فعال، برای ارزیابی نان اینفریور بودن اثربخشی درمانی و ایمنی پرکینرا (ساخته شده توسط شرکت پرسیس ژن پار) در مقایسه با Keniret (محصول مرجع، ساخته شده توسط شرکت SOBi) در آرتریت ایدیوپاتیک سیستمیک جوانان
مطالعه بالینی فاز 3 تصادفی سازی شده، دو بازویی، موازی، دو سوکور، کنترل فعال، برای ارزیابی نان اینفریور بودن اثربخشی درمانی و ایمنی پرکینرا (ساخته شده توسط شرکت پرسیس ژن پار) در مقایسه با Kineret (محصول مرجع، ساخته شده توسط شرکت SOBi) در آرتریت ایدیوپاتیک سیستمیک جوانان
مطالعه بالینی فاز 3 تصادفی سازی شده، دو بازویی، موازی، دو سوکور، کنترل فعال، برای ارزیابی نان اینفریور بودن اثربخشی درمانی و ایمنی پرکینرا (ساخته شده توسط شرکت پرسیس ژن پار) در مقایسه با KeniretKineret (محصول مرجع، ساخته شده توسط شرکت SOBi) در آرتریت ایدیوپاتیک سیستمیک جوانان
Under the age of 16
At least 10 kg
Juvenile Arthritis subject based on ILAR criteria (2018 version)
Obtaining written informed consent from patients
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
Under the age of 16 AtWeight at least 10 kg Systemic Juvenile Arthritis subject based on ILAR criteria (2018 version) Obtaining written informed consent from patients
افراد با سن کمتر از 16 سال
حداقل وزن 10 کیلوگرم
مورد آرتریت جوانان فعال براساس کرایتریای ILAR (نسخه 2018)
دریافت رضایت نامه آگاهانه از بیمار
افراد با سن کمتر از 16 سال
حداقل وزن 10 کیلوگرم
مورد آرتریت سیستمیک جوانان فعال براساس کرایتریای ILAR (نسخه 2018)
دریافت رضایت نامه آگاهانه از بیمار
افراد با سن کمتر از 16 سال حداقل وزن 10 کیلوگرم مورد آرتریت سیستمیک جوانان فعال براساس کرایتریای ILAR (نسخه 2018) دریافت رضایت نامه آگاهانه از بیمار
Positive PDD Test
Patients with 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 not to change the dose during 1 week before study
Administration of Anakinra, Canakinumab or any Interleukin 1 inhibitors.
Administration of Live-attenuated vaccines within 2 weeks before study or have plan for it during the study.
History of allergic reaction to Biopharmaceutical or any constituents of formulation.
patients with Kawasaki based on echocardiography
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
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 patientsPatients with history of Thrombocytopeniathrombocytopenia or Leukopenialeukopenia 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 not todose change the dose during 1 week before study Administration of Anakinra, Canakinumab or any Interleukin 1 inhibitors drugs. Administration of Livelive-attenuated vaccines within 2 weeks before study or have plan for it during the study. History of allergic reaction to Biopharmaceuticalbiologic agents or any constituents of formulation. patientsPatients with Kawasaki based on echocardiography
تست PPD مثبت
بیمارانی که هپاتیت B و یا C فعال داشته باشند.
بیمارانی که آنتی بادی آنتی ژن سطحی ویروس هپاتیت B و یا آنتی بادی ویروس هپاتیت C، برای آنها مثبت باشد
بیمارانی که سابقه مشخص ابتلا به عفونت HIV را داشته باشند.
بیماران مبتلا به ترومبوسیتوپنی یا لکوپنی
بیماران با سطح هموگلوبین کمتر از 7.5 گرم در دسی لیتر
بیماران با آنزیمهای کبدیِ آسپارتات ترانس آمیناز (AST) و آلانین ترانس آمیناز (ALT) به میزان 2 برابر حد نرمال
بیماران مبتلا به عفونت فعال (بر اساس پاسخ آزمایش های مربوطه و کشت ادرار) به طوری که طی 8 هفته قبل از غربالگری، با آنتی بیوتیک تزریقی و یا طی 2 هفته قبل از غربالگری، با آنتی بیوتیک خوراکی تحت درمان قرار گرفته باشند.
بیمارانی که سابقه بدخیمی طی 5 سال قبل از غربالگری بر اساس رادیوگرافی سینوس و نمونه برداری های انجام شده داشته باشند.
اگر بیمار در حال دریافت کورتیکواستروئید باشد و 1 هفته قبل از شروع مطالعه دوز آن تغییر نکرده باشد.
بیمارانی که سابقه درمان قبلی با داروی آناکینرا، کاناکینومب یا سایر داروهای مهارکننده اینترلوکین 1 را دارند.
بیمارانی که کمتر از 2 هفته قبل از شروع مطالعه از واکسن زنده ضعیف شده استفاده نموده اند و یا در طول مطالعه برنامه ای جهت دریافت واکسن زنده داشته باشند.
واکنش حساسیتی به داروهای بیولوژیک یا هر یک از اجزای فرمولاسیون دارو.
ابتلا به بیماری کاوازاکی بر اساس اکوکاردیوگرافی های انجام شده.
تست PPD مثبت
بیمارانی که هپاتیت B و یا C فعال داشته باشند.
بیمارانی که آنتی بادی آنتی ژن سطحی ویروس هپاتیت B و یا آنتی بادی ویروس هپاتیت C، برای آنها مثبت باشد
بیمارانی که سابقه مشخص ابتلا به عفونت HIV را داشته باشند.
بیماران مبتلا به ترومبوسیتوپنی یا لکوپنی
بیماران با سطح هموگلوبین کمتر از 7.5 گرم در دسی لیتر
بیماران با آنزیمهای کبدیِ آسپارتات ترانس آمیناز (AST) و آلانین ترانس آمیناز (ALT) به میزان 2 برابر حد نرمال
بیماران مبتلا به عفونت فعال (بر اساس پاسخ آزمایش های مربوطه و کشت ادرار) به طوری که طی 8 هفته قبل از غربالگری، با آنتی بیوتیک تزریقی و یا طی 2 هفته قبل از غربالگری، با آنتی بیوتیک خوراکی تحت درمان قرار گرفته باشند.
بیمارانی که سابقه بدخیمی طی 5 سال قبل از غربالگری بر اساس رادیوگرافی سینوس و نمونه برداری های انجام شده داشته باشند.
اگر بیمار در حال دریافت کورتیکواستروئید باشد و 1 هفته قبل از شروع مطالعه دوز آن تغییر کرده باشد.
بیمارانی که سابقه درمان قبلی با داروی آناکینرا، کاناکینومب یا سایر داروهای مهارکننده اینترلوکین 1 را دارند.
بیمارانی که کمتر از 2 هفته قبل از شروع مطالعه از واکسن زنده ضعیف شده استفاده نموده اند و یا در طول مطالعه برنامه ای جهت دریافت واکسن زنده داشته باشند.
واکنش حساسیتی به داروهای بیولوژیک یا هر یک از اجزای فرمولاسیون دارو.
ابتلا به بیماری کاوازاکی بر اساس اکوکاردیوگرافی های انجام شده.
تست PPD مثبت بیمارانی که هپاتیت B و یا C فعال داشته باشند. بیمارانی که آنتی بادی آنتی ژن سطحی ویروس هپاتیت B و یا آنتی بادی ویروس هپاتیت C، برای آنها مثبت باشد بیمارانی که سابقه مشخص ابتلا به عفونت HIV را داشته باشند. بیماران مبتلا به ترومبوسیتوپنی یا لکوپنی بیماران با سطح هموگلوبین کمتر از 7.5 گرم در دسی لیتر بیماران با آنزیمهای کبدیِ آسپارتات ترانس آمیناز (AST) و آلانین ترانس آمیناز (ALT) به میزان 2 برابر حد نرمال بیماران مبتلا به عفونت فعال (بر اساس پاسخ آزمایش های مربوطه و کشت ادرار) به طوری که طی 8 هفته قبل از غربالگری، با آنتی بیوتیک تزریقی و یا طی 2 هفته قبل از غربالگری، با آنتی بیوتیک خوراکی تحت درمان قرار گرفته باشند. بیمارانی که سابقه بدخیمی طی 5 سال قبل از غربالگری بر اساس رادیوگرافی سینوس و نمونه برداری های انجام شده داشته باشند. اگر بیمار در حال دریافت کورتیکواستروئید باشد و 1 هفته قبل از شروع مطالعه دوز آن تغییر نکردهکرده باشد. بیمارانی که سابقه درمان قبلی با داروی آناکینرا، کاناکینومب یا سایر داروهای مهارکننده اینترلوکین 1 را دارند. بیمارانی که کمتر از 2 هفته قبل از شروع مطالعه از واکسن زنده ضعیف شده استفاده نموده اند و یا در طول مطالعه برنامه ای جهت دریافت واکسن زنده داشته باشند. واکنش حساسیتی به داروهای بیولوژیک یا هر یک از اجزای فرمولاسیون دارو. ابتلا به بیماری کاوازاکی بر اساس اکوکاردیوگرافی های انجام شده.
Randomization sequences for patients will be made online. 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 .
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 .
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 .
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.
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.
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.
medical response based on American College of Rheumatology (ACR)
Medical response based on American College of Rheumatology (ACR)
medicalMedical response based on American College of Rheumatology (ACR)
Percentage of disease's progress based on doctor's opinion (score 0-10), Evaluation of
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
Percentage of disease's progress based on doctor's opinion (score 0-10), Evaluationgeneral 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
week-4 to -8, 12, 24
Week-4 to -8, 12, 24
weekWeek-4 to -8, 12, 24
#2
treatment response in general activity ratio
Treatment response in overall assessment of disease ratio
treatmentTreatment response in general activityoverall assessment of disease ratio
نسبت پاسخ دهندگان به درمان در میزان فعالیت کلی بیماری
نسبت پاسخ دهندگان به درمان در ارزیابی کلی بیماری
نسبت پاسخ دهندگان به درمان در میزان فعالیتارزیابی کلی بیماری
week-4 to -8, 12, 24
Week-4 to -8, 12, 24
weekWeek-4 to -8, 12, 24
based on physician assessment
Based on patient assessment
basedBased on physicianpatient assessment
بر اساس نظر پزشک
بر اساس نظر بیمار
بر اساس نظر پزشکبیمار
#3
treatment response in overall assessment of disease ratio
Decrease in inflamed joints ratio
treatment responseDecrease in overall assessment of diseaseinflamed joints ratio
نسبت پاسخ دهندگان به درمان در ارزیابی کلی بیماری
نسبت پاسخ دهندگان به کاهش میزان مفاصل ملتهب
نسبت پاسخ دهندگان به درمان در ارزیابی کلی بیماریکاهش میزان مفاصل ملتهب
week-4 to -8, 12, 24
Week-4 to -8, 12, 24
weekWeek-4 to -8, 12, 24
based on patient assessment
Based on physician examination
basedBased on patient assessmentphysician examination
بر اساس نظر بیمار
براساس معاینه پزشک
بر اساس نظر بیماربراساس معاینه پزشک
#4
Decrease in inflamed joints ratio
Decrease in number of joints with movement restriction ratio
Decrease in inflamednumber of joints with movement restriction ratio
نسبت پاسخ دهندگان به کاهش میزان مفاصل ملتهب
نسبت پاسخ دهندگان به کاهش تعداد مفاصل دارای محدودیت حرکت
نسبت پاسخ دهندگان به کاهش میزانتعداد مفاصل ملتهبدارای محدودیت حرکت
week-4 to -8, 12, 24
Week-4 to -8, 12, 24
weekWeek-4 to -8, 12, 24
براساس معاینه پزشک
بر اساس معاینه پزشک
براساسبر اساس معاینه پزشک
#5
Decrease in number of joints with movement restriction ratio
Response to function improvement ratio
Decrease in number of joints with movement restrictionResponse to function improvement ratio
نسبت پاسخ دهندگان به کاهش تعداد مفاصل دارای محدودیت حرکت
نسبت پاسخ دهندگان به بهبود توانایی عملکرد
نسبت پاسخ دهندگان به کاهش تعداد مفاصل دارای محدودیت حرکتبهبود توانایی عملکرد
week-4 to -8, 12, 24
Week-4 to -8, 12, 24
weekWeek-4 to -8, 12, 24
Based on physician examination
Based on standardized and validated CHAQ Persian questionnaire
Based on physician examinationstandardized and validated CHAQ Persian questionnaire
بر اساس معاینه پزشک
بر اساس پرسشنامه CHAQ فارسی استاندارد و اعتبار سنجی شده
بر اساس معاینه پزشکپرسشنامه CHAQ فارسی استاندارد و اعتبار سنجی شده
#6
Response to function improvement ratio
Decrease in CRP and ESR level
Response to function improvement ratioDecrease in CRP and ESR level
نسبت پاسخ دهندگان به بهبود توانایی عملکرد
نسبت پاسخ دهندگان به کاهش سطح CRP و ESR
نسبت پاسخ دهندگان به بهبود توانایی عملکردکاهش سطح CRP و ESR
week-4 to -8, 12, 24
Week-4 to -8, 12, 24
weekWeek-4 to -8, 12, 24
Based on standardized and validated CHAQ Persian questionnaire
Laboratory test
Based on standardized and validated CHAQ Persian questionnaireLaboratory test
بر اساس پرسشنامه CHAQ فارسی استاندارد و اعتبار سنجی شده
تست آزمایشگاهی
بر اساس پرسشنامه CHAQ فارسی استاندارد و اعتبار سنجی شدهتست آزمایشگاهی
#7
Decrease in CRP and ESR level
ADE
Decrease in CRP and ESR levelADE
نسبت پاسخ دهندگان به کاهش سطح CRP و ESR
عوارض جانبی و واکنش دارویی ناخواسته
نسبت پاسخ دهندگان به کاهش سطح CRPعوارض جانبی و ESRواکنش دارویی ناخواسته
Screening visit, day 0, and weeks 1, 2, 4, 8, 12, 16, 20, 24
Screening Visit, Week 12, 24
Screening visitVisit, day 0, and weeks 1, 2, 4, 8,Week 12, 16, 20, 24
ویزیت غربالگری، روز 0 و هفته های 1، 2، 4، 8، 12، 16، 20 و24
ویزیت غربالگری، هفته 12 و 24
ویزیت غربالگری، روز 0هفته 12 و هفته های 1، 2، 4، 8، 12، 16، 20 و2424
Body Temperature, Respiratory Rate, Blood Pressure, Heart Rate
Clinical Lab Tests (LFT, Kidney Function, CBC and Biochemical Tests)
Body TemperatureClinical Lab Tests (LFT, Respiratory RateKidney Function, Blood Pressure, Heart RateCBC and Biochemical Tests)
دمای بدن، سرعت تنفسی، فشار خون و ضربان قلب
تست های آزمایشگاهی بالینی شامل فعالیت کبدی، فعالیت کلیوی، شمارش کامل سلولهای خونی و تست های بیوشیمی
دمای بدنتست های آزمایشگاهی بالینی شامل فعالیت کبدی، سرعت تنفسیفعالیت کلیوی، فشار خونشمارش کامل سلولهای خونی و ضربان قلبتست های بیوشیمی
#11
Systemic Immunological assessment
Immunogenicity
Systemic Immunological assessmentImmunogenicity
ارزیابی ایمنی سیستمیک
بررسی ایمونوژنیسته
ارزیابی ایمنی سیستمیکبررسی ایمونوژنیسته
Screening Visit, Week 12, 24
Day 0, Weeks 12, 24
Screening VisitDay 0, WeekWeeks 12, 24
ویزیت غربالگری، هفته 12 و 24
روز 0 و هفته های 12 و 24
ویزیت غربالگری،روز 0 و هفته های 12 و 24
Clinical Lab Tests (LFT, Kidney Function, CBC and Biochemical Tests)
Antibody against Drug evaluation
Clinical Lab Tests (LFT, Kidney Function, CBC and Biochemical Tests)Antibody against Drug evaluation
تست های آزمایشگاهی بالینی شامل فعالیت کبدی، فعالیت کلیوی، شمارش کامل سلولهای خونی و تست های بیوشیمی
سنجش تشکیل آنتی بادی علیه دارو
تست های آزمایشگاهی بالینی شامل فعالیت کبدی، فعالیت کلیوی، شمارش کامل سلولهای خونی و تست های بیوشیمیسنجش تشکیل آنتی بادی علیه دارو
#12
Immunogenicity
The ratio of respondents to treatment in the overall activity rate of the disease
ImmunogenicityThe ratio of respondents to treatment in the overall activity rate of the disease
بررسی ایمونوژنیسته
نسبت پاسخ دهندگان به درمان در میزان فعالیت کلی بیماری
بررسی ایمونوژنیستهنسبت پاسخ دهندگان به درمان در میزان فعالیت کلی بیماری
day 0, Weeks 12, 24
Screening visit, week 12 and 24
day 0Screening visit, Weeksweek 12, and 24
روز 0 و هفته های 12 و 24
ویزیت غربالگری، هفته 12 و هفته 24
روز 0ویزیت غربالگری، هفته 12 و هفته های 12 و 24
Antibody against Drug evaluation
Based on patient assessment
Antibody against Drug evaluationBased on patient assessment
سنجش تشکیل آنتی بادی علیه دارو
بر اساس نظر بیمار
سنجش تشکیل آنتی بادی علیه داروبر اساس نظر بیمار
Recruitment centers
#1
Name of recruitment center - English: Rheumatology Department, Mofid Children Hospital
Name of recruitment center - Persian: بخش روماتولوژی بیمارستان تخصصی-فوق تخصصی کودکان مفید
Full name of responsible person - English: Dr. Reza Shiarei
Full name of responsible person - Persian: دکتر رضا شیاری
Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran
Street address - Persian: خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی-فوق تخصصی کودکان مفید
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 15514- 15468
Phone: +98 21 2222 7021
Fax: +98 21 2222 0254
Email: info-mch@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Rheumatology Department, Mofid Children Hospital
Name of recruitment center - Persian: بخش روماتولوژی بیمارستان تخصصی-فوق تخصصی کودکان مفید
Full name of responsible person - English: Dr. Reza Shiarei
Full name of responsible person - Persian: دکتر رضا شیاری
Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran
Street address - Persian: خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی-فوق تخصصی کودکان مفید
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 15514- 15468
Phone: +98 21 2222 7021
Fax: +98 21 2222 0254
Email: shiareza@yahoo.com
Web page address: http://mch.sbmu.ac.ir/uploads/cv-dr-reza-shiari.pdf
Name of recruitment center - English: Rheumatology Department, Mofid Children Hospital Name of recruitment center - Persian: بخش روماتولوژی بیمارستان تخصصی-فوق تخصصی کودکان مفید Full name of responsible person - English: Dr. Reza Shiarei Full name of responsible person - Persian: دکتر رضا شیاری Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran Street address - Persian: خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی-فوق تخصصی کودکان مفید City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 15514- 15468 Phone: +98 21 2222 7021 Fax: +98 21 2222 0254 Email: info-mchshiareza@sbmu.ac.iryahoo.com Web page address: http://mch.sbmu.ac.ir/uploads/cv-dr-reza-shiari.pdf
#2
Name of recruitment center - English: rheumatology department, Namazi Hospital
Name of recruitment center - Persian: بخش روماتولوژی بیمارستان نمازی
Full name of responsible person - English: Dr. Shabnam Hajiani
Full name of responsible person - Persian: دکتر شبنم حاجیانی
Street address - English: Namazi Sq., Zand St., Shiraz
Street address - Persian: فارس، شیراز، خیابان زند، میدان نمازی، بیمارستان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7193613311
Phone: +98 71 3647 4332
Fax: +98 71 3647 4326
Email: sh_h86@yahoo.com
Web page address:
Name of recruitment center - English: rheumatology department, Namazi Hospital Name of recruitment center - Persian: بخش روماتولوژی بیمارستان نمازی Full name of responsible person - English: Dr. Shabnam Hajiani Full name of responsible person - Persian: دکتر شبنم حاجیانی Street address - English: Namazi Sq., Zand St., Shiraz Street address - Persian: فارس، شیراز، خیابان زند، میدان نمازی، بیمارستان نمازی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7193613311 Phone: +98 71 3647 4332 Fax: +98 71 3647 4326 Email: sh_h86@yahoo.com Web page address:
#3
Name of recruitment center - English: rheumatology department, Afzali Poor Hospital
Name of recruitment center - Persian: بخش روماتولوژی بیمارستان افضلی پور
Full name of responsible person - English: Dr. Reza Sinaei
Full name of responsible person - Persian: دکتر رضا سینایی
Street address - English: Emam Blvd, Kerman
Street address - Persian: کرمان، بزرگراه امام
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913911
Phone: +98 34 3132 8000
Fax: +98 34 3325 7770
Email: Sinaei.rz@gmail.com
Web page address:
Name of recruitment center - English: rheumatology department, Afzali Poor Hospital Name of recruitment center - Persian: بخش روماتولوژی بیمارستان افضلی پور Full name of responsible person - English: Dr. Reza Sinaei Full name of responsible person - Persian: دکتر رضا سینایی Street address - English: Emam Blvd, Kerman Street address - Persian: کرمان، بزرگراه امام City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7616913911 Phone: +98 34 3132 8000 Fax: +98 34 3325 7770 Email: Sinaei.rz@gmail.com Web page address:
#4
Name of recruitment center - English: rheumatology department, 17 Sharivar Children Hospital
Name of recruitment center - Persian: بخش روماتولوژی بیمارستان کودکان 17 شهریور
Full name of responsible person - English: Dr. Aye Mir Emarati
Full name of responsible person - Persian: دکتر آیه میرعمارتی
Street address - English: Saadati St, Namjoo Blvd, Rasht
Street address - Persian: رشت، بلوار نامجو، خیابان سعادتی
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4144654379
Phone: +98 13 3336 9391
Fax: +98 13 3336 9070
Email: ayemiremarati@gmail.com
Web page address:
Name of recruitment center - English: rheumatology department, 17 Sharivar Children Hospital Name of recruitment center - Persian: بخش روماتولوژی بیمارستان کودکان 17 شهریور Full name of responsible person - English: Dr. Aye Mir Emarati Full name of responsible person - Persian: دکتر آیه میرعمارتی Street address - English: Saadati St, Namjoo Blvd, Rasht Street address - Persian: رشت، بلوار نامجو، خیابان سعادتی City - English: Rasht City - Persian: رشت Province: Guilan Country: Iran (Islamic Republic of) Postal code: 4144654379 Phone: +98 13 3336 9391 Fax: +98 13 3336 9070 Email: ayemiremarati@gmail.com Web page address:
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Trial Research Company
Name of organization / entity - Persian: شرکت پژوهشی ترایال
Full name of responsible person - English: Dr. Seyyed Hamed Hosseini
Full name of responsible person - Persian: دکتر سید حامد حسینی
Position - English: manager of clinical trial center
Position - Persian: مدیر مرکز کارآزمایی بالینی
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Unit 23, 4th Floor, NO. 1547, Tehran University of Medical Science Research Center, North Kargar st., Before Keshavarz Blvd, Tehran
Street address - Persian: خیابان کارگر شمالی، نرسیده به بلوار کشاورز، مجتمع پژوهشکده ها و مراکز تحقیقاتی دانشگاه علوم پزشکی تهران، پلاک 1547، طبقه 4، واحد 23
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417993337
Phone: +98 21 8896 3546
Mobile: +98 913 341 1750
Fax:
Email: ctc@tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Trial Research Company
Name of organization / entity - Persian: شرکت پژوهشی ترایال
Full name of responsible person - English: Dr. Seyyed Hamed Hosseini
Full name of responsible person - Persian: دکتر سید حامد حسینی
Position - English: Manager of clinical trial center
Position - Persian: مدیر مرکز کارآزمایی بالینی
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Unit 23, 4th Floor, NO. 1547, Tehran University of Medical Science Research Center, North Kargar st., Before Keshavarz Blvd, Tehran
Street address - Persian: خیابان کارگر شمالی، نرسیده به بلوار کشاورز، مجتمع پژوهشکده ها و مراکز تحقیقاتی دانشگاه علوم پزشکی تهران، پلاک 1547، طبقه 4، واحد 23
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417993337
Phone: +98 21 8896 3546
Mobile: +98 913 341 1750
Fax:
Email: ctc@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Trial Research Company Name of organization / entity - Persian: شرکت پژوهشی ترایال Full name of responsible person - English: Dr. Seyyed Hamed Hosseini Full name of responsible person - Persian: دکتر سید حامد حسینی Position - English: managerManager of clinical trial center Position - Persian: مدیر مرکز کارآزمایی بالینی Latest degree: phd Area of specialty/work: 2 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Unit 23, 4th Floor, NO. 1547, Tehran University of Medical Science Research Center, North Kargar st., Before Keshavarz Blvd, Tehran Street address - Persian: خیابان کارگر شمالی، نرسیده به بلوار کشاورز، مجتمع پژوهشکده ها و مراکز تحقیقاتی دانشگاه علوم پزشکی تهران، پلاک 1547، طبقه 4، واحد 23 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1417993337 Phone: +98 21 8896 3546 Mobile: +98 913 341 1750 Fax: Email: ctc@tums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Reza Shiarei
Full name of responsible person - Persian: دکتر رضا شیاری
Position - English: pediatric rheumatologist
Position - Persian: فوق تخصص روماتولوژی کودکان
Latest degree: sub_specialist
Area of specialty/work:
Area of specialty/work title - English: rheumatology, Pediatric
Area of specialty/work title - Persian: روماتولوژی، اطفال
Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran
Street address - Persian: خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی- فوق تخصصی کودکان مفید، طبقه چهارم، بخش روماتولوژی کودکان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 15514- 15468
Phone: +98 21 2641 1681
Mobile: +98 912 640 8577
Fax:
Email: shiareza@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Reza Shiarei
Full name of responsible person - Persian: دکتر رضا شیاری
Position - English: Pediatric rheumatologist
Position - Persian: فوق تخصص روماتولوژی کودکان
Latest degree: sub_specialist
Area of specialty/work:
Area of specialty/work title - English: Rheumatology, Pediatric
Area of specialty/work title - Persian: روماتولوژی، اطفال
Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran
Street address - Persian: خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی- فوق تخصصی کودکان مفید، طبقه چهارم، بخش روماتولوژی کودکان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 15514- 15468
Phone: +98 21 2641 1681
Mobile: +98 912 640 8577
Fax:
Email: shiareza@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Reza Shiarei Full name of responsible person - Persian: دکتر رضا شیاری Position - English: pediatricPediatric rheumatologist Position - Persian: فوق تخصص روماتولوژی کودکان Latest degree: sub_specialist Area of specialty/work: Area of specialty/work title - English: rheumatologyRheumatology, Pediatric Area of specialty/work title - Persian: روماتولوژی، اطفال Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran Street address - Persian: خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی- فوق تخصصی کودکان مفید، طبقه چهارم، بخش روماتولوژی کودکان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 15514- 15468 Phone: +98 21 2641 1681 Mobile: +98 912 640 8577 Fax: Email: shiareza@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Reza Shiarei
Full name of responsible person - Persian: دکتر رضا شیاری
Position - English: pediatric rheumatologist
Position - Persian: فوق تخصص روماتولوژی کودکان
Latest degree: sub_specialist
Area of specialty/work:
Area of specialty/work title - English: rheumatology, Pediatric
Area of specialty/work title - Persian: روماتولوژی، اطفال
Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran
Street address - Persian: تهران، خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی- فوق تخصصی کودکان مفید، طبقه چهارم، بخش روماتولوژی کودکان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 15514- 15468
Phone: +98 21 2641 1681
Mobile: +98 912 640 8577
Fax:
Email: shiareza@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Reza Shiarei
Full name of responsible person - Persian: دکتر رضا شیاری
Position - English: Pediatric rheumatologist
Position - Persian: فوق تخصص روماتولوژی کودکان
Latest degree: sub_specialist
Area of specialty/work:
Area of specialty/work title - English: Rheumatology, Pediatric
Area of specialty/work title - Persian: روماتولوژی، اطفال
Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran
Street address - Persian: تهران، خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی- فوق تخصصی کودکان مفید، طبقه چهارم، بخش روماتولوژی کودکان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 15514- 15468
Phone: +98 21 2641 1681
Mobile: +98 912 640 8577
Fax:
Email: shiareza@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Reza Shiarei Full name of responsible person - Persian: دکتر رضا شیاری Position - English: pediatricPediatric rheumatologist Position - Persian: فوق تخصص روماتولوژی کودکان Latest degree: sub_specialist Area of specialty/work: Area of specialty/work title - English: rheumatologyRheumatology, Pediatric Area of specialty/work title - Persian: روماتولوژی، اطفال Street address - English: Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran Street address - Persian: تهران، خیابان دکتر شریعتی، روبروی حسینیه ارشاد، بیمارستان تخصصی- فوق تخصصی کودکان مفید، طبقه چهارم، بخش روماتولوژی کودکان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 15514- 15468 Phone: +98 21 2641 1681 Mobile: +98 912 640 8577 Fax: Email: shiareza@yahoo.com Web page address:
Sharing plan
clinical trial data is confidential and dedicated to the company.
Clinical trial data is confidential and dedicated to the company.
clinicalClinical trial data is confidential and dedicated to the company.
Protocol summary
Study aim
Evaluate the efficacy and safety of PerkinRA ( manufactured by PersisgenPar CO) in comparison with Kineret (Reference product, manufactured by SOBi )
Design
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
Settings and conduct
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 .
Participants/Inclusion and exclusion criteria
Age under 16 years, weight at least 10 kg, Systemic Juvenile Arthritis subject based on ILAR criteria, obtaining written informed consent from patients
Intervention groups
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.
Main outcome variables
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
Reason for update
Increasing the number of patient enrollment centers
Acronym
IRCT registration information
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
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
Reza Shiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7033
Email address
shiareza@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Clinical trial of PerkinRA in comparison with Kineret® (manufactured by SOBi)
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 1 year old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Science
Street address
Research and technology deputy, Building no. 2, Shahid Beheshti University of Medical Science, Evin
City
Tehran
Province
Tehran
Postal code
134423235
Approval date
2020-02-09, 1398/11/20
Ethics committee reference number
IR.SBMU.REC.1398.161
2
Ethics committee
Name of ethics committee
Deputy of research and technology of Tehran university of medical sciences
Street address
Keshavarz Blv, Qods street, University Central organization, sixth floor
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.TUMS.VCR.REC.1398.992
Health conditions studied
1
Description of health condition studied
Systematic Juvenile Idiopathic Arthritis
ICD-10 code
M08.0
ICD-10 code description
Unspecified juvenile rheumatoid arthritis
Primary outcomes
1
Description
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 outcomes
1
Description
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
2
Description
Treatment response in overall assessment of disease ratio
Timepoint
Week-4 to -8, 12, 24
Method of measurement
Based on patient assessment
3
Description
Decrease in inflamed joints ratio
Timepoint
Week-4 to -8, 12, 24
Method of measurement
Based on physician examination
4
Description
Decrease in number of joints with movement restriction ratio
Timepoint
Week-4 to -8, 12, 24
Method of measurement
Based on physician examination
5
Description
Response to function improvement ratio
Timepoint
Week-4 to -8, 12, 24
Method of measurement
Based on standardized and validated CHAQ Persian questionnaire
6
Description
Decrease in CRP and ESR level
Timepoint
Week-4 to -8, 12, 24
Method of measurement
Laboratory test
7
Description
ADE
Timepoint
Day 0, weeks 1, 2, 4, 8,12, 16, 20, 24
Method of measurement
Questionnaire
8
Description
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
9
Description
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
10
Description
Systemic Immunological assessment
Timepoint
Screening Visit, Week 12, 24
Method of measurement
Clinical Lab Tests (LFT, Kidney Function, CBC and Biochemical Tests)
11
Description
Immunogenicity
Timepoint
Day 0, Weeks 12, 24
Method of measurement
Antibody against Drug evaluation
12
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Department, Mofid Children Hospital
Full name of responsible person
Dr. Reza Shiarei
Street address
Rheumatology Department, Fourth Floor, Mofid Children Hospital, in front of the Hosseinieh Ershad Hospital, Dr. Shariati St., Tehran