A phase 3, randomized, multicenter, double-blind, two-armed, parallel, active-controlled, Non-inferiority clinical trial to compare efficacy and safety of Infliximab (Infliximab produced by AryoGen Pharmed co) versus Remicade® (Infliximab produced by Janssen Immunology co.) in patients with active moderate to severe Ulcerative Colitis
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Recruitment centers
#1
Name of recruitment center - English: Shariati Hospital
Name of recruitment center - Persian: مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتی
Full name of responsible person - English: Amir Anoushirvani
Full name of responsible person - Persian: امیر انوشیروانی
Street address - English: Ale-Ahmad Junc, Karegar Ave,Tehran, Iran
Street address - Persian: خیابان کارگر شمالی، سه راه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713135
Phone: +98 21 8490 1000
Fax:
Email: amiranush@gmail.com
Web page address:
Name of recruitment center - English: Masoud clinic
Name of recruitment center - Persian: کلینیک مسعود
Full name of responsible person - English: Amir Anoushirvani
Full name of responsible person - Persian: امیر انوشیروانی
Street address - English: No. 144, 19th Alley, North Kargar Ave
Street address - Persian: خیابان كارگر شمالي، كوچه 19، پلاك 144
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439963553
Phone: +98 917 316 0616
Fax:
Email: amiranush@gmail.com
Web page address:
Name of recruitment center - English: Shariati HospitalMasoud clinic Name of recruitment center - Persian: مرکز آموزشی پژوهشی و درمانی بیمارستان شریعتیکلینیک مسعود Full name of responsible person - English: Amir Anoushirvani Full name of responsible person - Persian: امیر انوشیروانی Street address - English: Ale-Ahmad JuncNo. 144, Karegar Ave,Tehran19th Alley, IranNorth Kargar Ave Street address - Persian: خیابان کارگر شمالیكارگر شمالي، سه راه جلال آل احمدكوچه 19، پلاك 144 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14117131351439963553 Phone: +98 21 8490 1000917 316 0616 Fax: Email: amiranush@gmail.com Web page address:
#2
Name of recruitment center - English: Hospital of Hazrat Rasool Akram
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Marjan Mokhtare
Full name of responsible person - Persian: مرجان مخترع
Street address - English: Starkhan-Khan, Niayesh Street, Corner of Mansouri Street
Street address - Persian: ستارخان، خیابان نیایش، نبش خیابان منصوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 1000
Fax:
Email: marjanmokhtare@yahoo.com
Web page address:
Name of recruitment center - English: Masoud Clinic
Name of recruitment center - Persian: کلینیک مسعود
Full name of responsible person - English: Marjan Mokhtare
Full name of responsible person - Persian: مرجان مخترع
Street address - English: No. 144, Alley 19., North Kargar Ave
Street address - Persian: خیابان كارگر شمالي، كوچه 19، پلاك 144
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439963553
Phone: +98 911 156 8597
Fax:
Email: marjanmokhtare@yahoo.com
Web page address:
Name of recruitment center - English: Hospital of Hazrat Rasool AkramMasoud Clinic Name of recruitment center - Persian: بیمارستان حضرت رسول اکرمکلینیک مسعود Full name of responsible person - English: Marjan Mokhtare Full name of responsible person - Persian: مرجان مخترع Street address - English: Starkhan-KhanNo. 144, Niayesh StreetAlley 19., Corner of Mansouri StreetNorth Kargar Ave Street address - Persian: ستارخانخیابان كارگر شمالي، خیابان نیایشكوچه 19، نبش خیابان منصوریپلاك 144 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14456131311439963553 Phone: +98 21 6435 1000911 156 8597 Fax: Email: marjanmokhtare@yahoo.com Web page address:
#3
Name of recruitment center - English: Hospital of Hazrat Rasool Akram
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Shahram Agah
Full name of responsible person - Persian: شهرام آگاه
Street address - English: Starkhan-Khan, Niayesh Street, Mansouri Ave
Street address - Persian: ستارخان، خیابان نیایش، نبش خیابان منصوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 1000
Fax:
Email: shahramagah@gmail.com
Web page address:
Name of recruitment center - English: Professor Shahram Aghah Gastroenterology, Hepatology, and Endoscopy Specialty Clinic
Name of recruitment center - Persian: کلینیک فوق تخصصی گوارش و کبد و آندوسکوپی پروفسور شهرام آگاه
Full name of responsible person - English: Shahram Agah
Full name of responsible person - Persian: شهرام آگاه
Street address - English: Unit 24, No. 1, 9th Alley, North Side of Kaj Square (Shahid Tehrani Moghadam), Saadat Abad
Street address - Persian: سعادت آباد، ضلع شمالی میدان کاج (شهید طهرانی مقدم)، کوچه نهم، پلاک 1، واحد 24
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 912 327 8615
Fax:
Email: shahramagah@gmail.com
Web page address:
Name of recruitment center - English: Hospital of Hazrat Rasool AkramProfessor Shahram Aghah Gastroenterology, Hepatology, and Endoscopy Specialty Clinic Name of recruitment center - Persian: بیمارستان حضرت رسول اکرمکلینیک فوق تخصصی گوارش و کبد و آندوسکوپی پروفسور شهرام آگاه Full name of responsible person - English: Shahram Agah Full name of responsible person - Persian: شهرام آگاه Street address - English: Starkhan-KhanUnit 24, Niayesh StreetNo. 1, Mansouri Ave9th Alley, North Side of Kaj Square (Shahid Tehrani Moghadam), Saadat Abad Street address - Persian: ستارخانسعادت آباد، خیابان نیایشضلع شمالی میدان کاج (شهید طهرانی مقدم)، نبش خیابان منصوریکوچه نهم، پلاک 1، واحد 24 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 1000912 327 8615 Fax: Email: shahramagah@gmail.com Web page address:
#4
Name of recruitment center - English: Namazi Hospital
Name of recruitment center - Persian: بیمارستان نمازی
Full name of responsible person - English: Kamran Bagheri Lankarani
Full name of responsible person - Persian: کامران باقری لنکرانی
Street address - English: Zand Street, Namazi Square
Street address - Persian: خیابان زند، میدان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 1135171937
Phone: +98 61 3647 4332
Fax:
Email: kblankarani@gmail.com
Web page address:
Name of recruitment center - English: Faghihi Hospital
Name of recruitment center - Persian: بیمارستان دکتر فقیهی
Full name of responsible person - English: Kamran Bagheri Lankarani
Full name of responsible person - Persian: کامران باقری لنکرانی
Street address - English: Karim Khan Zand Blvd, Next to the Faculty of Medicine
Street address - Persian: بلوار کریم خان زند، جنب دانشکده پزشکی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ۷۱۳۴۸۴۶۱۱۴
Phone: +98 917 118 4083
Fax:
Email: kblankarani@gmail.com
Web page address:
Name of recruitment center - English: NamaziFaghihi Hospital Name of recruitment center - Persian: بیمارستان نمازیدکتر فقیهی Full name of responsible person - English: Kamran Bagheri Lankarani Full name of responsible person - Persian: کامران باقری لنکرانی Street address - English: Karim Khan Zand StreetBlvd, Namazi SquareNext to the Faculty of Medicine Street address - Persian: خیابانبلوار کریم خان زند، میدان نمازیجنب دانشکده پزشکی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 1135171937۷۱۳۴۸۴۶۱۱۴ Phone: +98 61 3647 4332917 118 4083 Fax: Email: kblankarani@gmail.com Web page address:
#5
Name of recruitment center - English: Ghaem Hospital
Name of recruitment center - Persian: درمانگاه مرکزی مرکز آموزشی پژوهشی و درمانی قائم
Full name of responsible person - English: Hasan Vosoughinia
Full name of responsible person - Persian: حسن وثوقینیا
Street address - English: Ahmad-Abad Street, Shariati Square
Street address - Persian: میدان دکتر شریعتی، ابتدای خیابان احمد آباد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176691999
Phone: +98 51 3840 0000
Fax:
Email: vosoghiniah@mums.ac.ir
Web page address:
Name of recruitment center - English: Pazh Clinic
Name of recruitment center - Persian: کلینیک پاژ
Full name of responsible person - English: Hasan Vosoughinia
Full name of responsible person - Persian: حسن وثوقینیا
Street address - English: Atieh Medical Building., First Floor., Before Tak Complex., Between Dastgheib 33 and 35., Khayyam Blvd
Street address - Persian: بلوار خیام، بین دستغیب 33 و 35، نرسیده به مجتمع تک، ساختمان پزشکان آتیه، طبقه اول
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9185811111
Phone: +98 915 310 0263
Fax:
Email: vosoghiniah@mums.ac.ir
Web page address:
Name of recruitment center - English: Ghaem HospitalPazh Clinic Name of recruitment center - Persian: درمانگاه مرکزی مرکز آموزشی پژوهشی و درمانی قائمکلینیک پاژ Full name of responsible person - English: Hasan Vosoughinia Full name of responsible person - Persian: حسن وثوقینیا Street address - English: Ahmad-Abad StreetAtieh Medical Building., Shariati SquareFirst Floor., Before Tak Complex., Between Dastgheib 33 and 35., Khayyam Blvd Street address - Persian: میدان دکتر شریعتیبلوار خیام، ابتدای خیابان احمد آبادبین دستغیب 33 و 35، نرسیده به مجتمع تک، ساختمان پزشکان آتیه، طبقه اول City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91766919999185811111 Phone: +98 51 3840 0000915 310 0263 Fax: Email: vosoghiniah@mums.ac.ir Web page address:
#6
Name of recruitment center - English: Ghaem Hospital
Name of recruitment center - Persian: درمانگاه مرکزی مرکز آموزشی پژوهشی و درمانی قائم
Full name of responsible person - English: Ali Bahari
Full name of responsible person - Persian: علی بهاری
Street address - English: Ahmad-Abad Street, Shariati Square
Street address - Persian: میدان دکتر شریعتی، ابتدای خیابان احمد آباد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176691999
Phone: +98 51 3840 0000
Fax:
Email: Baharia@mums.ac.ir
Web page address:
Name of recruitment center - English: Emam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Ali Bahari
Full name of responsible person - Persian: علی بهاری
Street address - English: ٍEmam Reza Square., Ibn-e Sina Ave
Street address - Persian: خیابان ابن سینا، میدان امام رضا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: ٩١٣٧٩١٣٣١۶
Phone: +98 915 541 0429
Fax:
Email: Baharia@mums.ac.ir
Web page address:
Name of recruitment center - English: GhaemEmam Reza Hospital Name of recruitment center - Persian: درمانگاه مرکزی مرکز آموزشی پژوهشی و درمانی قائمبیمارستان امام رضا Full name of responsible person - English: Ali Bahari Full name of responsible person - Persian: علی بهاری Street address - English: Ahmad-Abad StreetٍEmam Reza Square., Shariati SquareIbn-e Sina Ave Street address - Persian: خیابان ابن سینا، میدان دکتر شریعتی، ابتدای خیابان احمد آبادامام رضا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9176691999٩١٣٧٩١٣٣١۶ Phone: +98 51 3840 0000915 541 0429 Fax: Email: Baharia@mums.ac.ir Web page address:
#7
Name of recruitment center - English: Alzahra Hospital
Name of recruitment center - Persian: بیمارستان الزهرا
Full name of responsible person - English: Babak Tamizifar
Full name of responsible person - Persian: بابک تمیزیفر
Street address - English: Soffeh Blvd, Shahid Keshvari High Way
Street address - Persian: بزرگراه شهید کشوری، بلوار صفه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174675731
Phone: +98 31 3822 0000
Fax:
Email: babaktamizifar@gmail.com
Web page address:
Name of recruitment center - English: Salamat clinic of Alzahra Hospital Hospital
Name of recruitment center - Persian: کلینیک سلامت بیمارستان الزهرا
Full name of responsible person - English: Babak Tamizifar
Full name of responsible person - Persian: بابک تمیزیفر
Street address - English: Soffeh Blvd, Shahid Keshvari High Way
Street address - Persian: بزرگراه شهید کشوری، بلوار صفه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174675731
Phone: +98 913 325 7859
Fax:
Email: babaktamizifar@gmail.com
Web page address:
Name of recruitment center - English: Salamat clinic of Alzahra Hospital Hospital Name of recruitment center - Persian: کلینیک سلامت بیمارستان الزهرا Full name of responsible person - English: Babak Tamizifar Full name of responsible person - Persian: بابک تمیزیفر Street address - English: Soffeh Blvd, Shahid Keshvari High Way Street address - Persian: بزرگراه شهید کشوری، بلوار صفه City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174675731 Phone: +98 31 3822 0000913 325 7859 Fax: Email: babaktamizifar@gmail.com Web page address:
#8
Name of recruitment center - English: Alzahra Hospital
Name of recruitment center - Persian: بیمارستان الزهرا
Full name of responsible person - English: Mohammad Hassan Emami Najafi Dehkordi
Full name of responsible person - Persian: محمدحسن امامی نجفی دهکردی
Street address - English: Soffeh Blvd, Shahid Keshvari High Way
Street address - Persian: بزرگراه شهید کشوری، بلوار صفه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174675731
Phone: +98 31 3822 0000
Fax:
Email: mh.emami1338@gmail.com
Web page address:
Name of recruitment center - English: Salamat Clinic of Alzahra Hospital
Name of recruitment center - Persian: کلینیک سلامت بیمارستان الزهرا
Full name of responsible person - English: Hadi Abdollahi
Full name of responsible person - Persian: هادی عبداللهی
Street address - English: Soffeh Blvd, Shahid Keshvari High Way
Street address - Persian: بزرگراه شهید کشوری، بلوار صفه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174675731
Phone: +98 913 117 2760
Fax:
Email: Hadi.abdolahi@yahoo.com
Web page address:
Name of recruitment center - English: Salamat Clinic of Alzahra Hospital Name of recruitment center - Persian: کلینیک سلامت بیمارستان الزهرا Full name of responsible person - English: Mohammad Hassan Emami Najafi DehkordiHadi Abdollahi Full name of responsible person - Persian: محمدحسن امامی نجفی دهکردیهادی عبداللهی Street address - English: Soffeh Blvd, Shahid Keshvari High Way Street address - Persian: بزرگراه شهید کشوری، بلوار صفه City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174675731 Phone: +98 31 3822 0000913 117 2760 Fax: Email: mh.emami1338Hadi.abdolahi@gmail.comyahoo.com Web page address:
#9
Name of recruitment center - English: Alzahra Hospital
Name of recruitment center - Persian: بیمارستان الزهرا
Full name of responsible person - English: Hadi Abdollahi
Full name of responsible person - Persian: هادی عبداللهی
Street address - English: Soffeh Blvd, Shahid Keshvari High Way
Street address - Persian: بزرگراه شهید کشوری، بلوار صفه
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174675731
Phone: +98 31 3822 0000
Fax:
Email: Hadi.abdolahi@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Iraj Maleki
Full name of responsible person - Persian: ایرج ملکی
Street address - English: Razi Ave, Valie-Asr Blvd,
Street address - Persian: بلوار ولیعصر، خیابان رازی
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 48166 33131
Phone: +98 11 3304 4000
Fax:
Email: iradj2001@yahoo.com
Web page address:
Name of recruitment center - English: AlzahraImam Khomeini Hospital Name of recruitment center - Persian: بیمارستان الزهراامام خمینی Full name of responsible person - English: Hadi AbdollahiIraj Maleki Full name of responsible person - Persian: هادی عبداللهیایرج ملکی Street address - English: SoffehRazi Ave, Valie-Asr Blvd, Shahid Keshvari High Way Street address - Persian: بزرگراه شهید کشوریبلوار ولیعصر، بلوار صفهخیابان رازی City - English: IsfahanSari City - Persian: اصفهانساری Province: IsfehanMazandaran Country: Iran (Islamic Republic of) Postal code: 817467573148166 33131 Phone: +98 31 3822 000011 3304 4000 Fax: Email: Hadi.abdolahiiradj2001@yahoo.com Web page address:
#10
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Iraj Maleki
Full name of responsible person - Persian: ایرج ملکی
Street address - English: Razi Ave, Valie-Asr Blvd,
Street address - Persian: بلوار ولیعصر، خیابان رازی
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 48166 33131
Phone: +98 11 3304 4000
Fax:
Email: iradj2001@yahoo.com
Web page address:
Name of recruitment center - English: Guilan Gastroenterology and Liver Specialist Clinic
Name of recruitment center - Persian: کلینیک فوق تخصصی گوارش و کبد گیلان
Full name of responsible person - English: Fariborz Mansour Ghanaei
Full name of responsible person - Persian: فریبرز منصور قناعی
Street address - English: Arsen Building, Imam Khomeini Ave., Before Heshmat Square
Street address - Persian: خیابان امام خمینی، نرسیده به میدان حشمت، ساختمان آرسن
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4136944501
Phone: +98 911 131 3787
Fax:
Email: ghanaie@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini HospitalGuilan Gastroenterology and Liver Specialist Clinic Name of recruitment center - Persian: بیمارستان امام خمینیکلینیک فوق تخصصی گوارش و کبد گیلان Full name of responsible person - English: Iraj MalekiFariborz Mansour Ghanaei Full name of responsible person - Persian: ایرج ملکیفریبرز منصور قناعی Street address - English: RaziArsen Building, Imam Khomeini Ave., Valie-Asr Blvd,Before Heshmat Square Street address - Persian: بلوار ولیعصرخیابان امام خمینی، خیابان رازینرسیده به میدان حشمت، ساختمان آرسن City - English: SariRasht City - Persian: ساریرشت Province: MazandaranGuilan Country: Iran (Islamic Republic of) Postal code: 48166 331314136944501 Phone: +98 11 3304 4000911 131 3787 Fax: Email: iradj2001ghanaie@yahoo.com Web page address:
#11
Name of recruitment center - English: Razi Hospital
Name of recruitment center - Persian: مرکز آموزشی درمانی رازی
Full name of responsible person - English: Fariborz Mansour Ghanaei
Full name of responsible person - Persian: فریبرز منصور قناعی
Street address - English: Sardar Jangal Street, Rasht, Iran
Street address - Persian: رشت، خیابان سردار جنگل، مرکز آموزشی درمانی رازی
City - English: Rasht
City - Persian: رشت
Province: Guilan
Country: Iran (Islamic Republic of)
Postal code: 4144895655
Phone: +98 13 3354 1001
Fax:
Email: ghanaie@yahoo.com
Web page address:
Name of recruitment center - English: Dr. Seyedhamid Moosavy clinic
Name of recruitment center - Persian: کلینیک دکتر سیدحمید موسوی
Full name of responsible person - English: Seyedhamid Moosavy
Full name of responsible person - Persian: سید حمید موسوی
Street address - English: Units 207 & 208, 2nd Floor, Arjin Building, Beginning of Seyyed Jamal-eddin Asadabadi Blvd, After the Daraii Intersection
Street address - Persian: بعد از سه راه دارایی، ابتدای بلوار سید جمال الدین اسد آبادی ساختمان آرژین طبقه دوم واحد 207 و 208
City - English: Bandarabbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7914690066
Phone: +98 917 763 5854
Fax:
Email: seyedhamid_moosavy@yahoo.com
Web page address:
Name of recruitment center - English: Razi HospitalDr. Seyedhamid Moosavy clinic Name of recruitment center - Persian: مرکز آموزشی درمانی رازیکلینیک دکتر سیدحمید موسوی Full name of responsible person - English: Fariborz Mansour GhanaeiSeyedhamid Moosavy Full name of responsible person - Persian: فریبرز منصور قناعیسید حمید موسوی Street address - English: Sardar Jangal StreetUnits 207 & 208, Rasht2nd Floor, IranArjin Building, Beginning of Seyyed Jamal-eddin Asadabadi Blvd, After the Daraii Intersection Street address - Persian: رشتبعد از سه راه دارایی، خیابان سردار جنگل، مرکز آموزشی درمانی رازیابتدای بلوار سید جمال الدین اسد آبادی ساختمان آرژین طبقه دوم واحد 207 و 208 City - English: RashtBandarabbas City - Persian: رشتبندرعباس Province: GuilanHormozgan Country: Iran (Islamic Republic of) Postal code: 41448956557914690066 Phone: +98 13 3354 1001917 763 5854 Fax: Email: ghanaieseyedhamid_moosavy@yahoo.com Web page address:
#12
Name of recruitment center - English: Payambar Azam Hospital
Name of recruitment center - Persian: بیمارستان پیامبر اعظم
Full name of responsible person - English: Seyedhamid Moosavy
Full name of responsible person - Persian: سید حمید موسوی
Street address - English: Jomhori Eslami Blvd
Street address - Persian: بلوار جمهوری اسلامی
City - English: Bandarabbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7919915519
Phone: +98 76 3334 7000
Fax:
Email: seyedhamid_moosavy@yahoo.com
Web page address:
Name of recruitment center - English: Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Javad Shokri
Full name of responsible person - Persian: جواد شکری
Street address - English: Sargord Ghasemi Ave
Street address - Persian: خیابان سرگرد قاسمی
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4716681451
Phone: +98 912 195 2294
Fax:
Email: javadshokry@gmail.com
Web page address:
Name of recruitment center - English: Payambar AzamShahid Beheshti Hospital Name of recruitment center - Persian: بیمارستان پیامبر اعظمشهید بهشتی Full name of responsible person - English: Seyedhamid MoosavyJavad Shokri Full name of responsible person - Persian: سید حمید موسویجواد شکری Street address - English: Jomhori Eslami BlvdSargord Ghasemi Ave Street address - Persian: بلوار جمهوری اسلامیخیابان سرگرد قاسمی City - English: BandarabbasBabol City - Persian: بندرعباسبابل Province: HormozganMazandaran Country: Iran (Islamic Republic of) Postal code: 79199155194716681451 Phone: +98 76 3334 7000912 195 2294 Fax: Email: seyedhamid_moosavyjavadshokry@yahoo.comgmail.com Web page address:
#13
Name of recruitment center - English: Masoud clinic
Name of recruitment center - Persian: کلینیک مسعود
Full name of responsible person - English: Alireza Sima
Full name of responsible person - Persian: علیرضا سیما
Street address - English: No. 144, 19th Alley, North Kargar Ave
Street address - Persian: خیابان كارگر شمالي، كوچه 19، پلاك 144
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439963553
Phone: +98 915 513 7188
Fax:
Email: simaalireza@gmail.com
Web page address:
Name of recruitment center - English: Masoud clinic Name of recruitment center - Persian: کلینیک مسعود Full name of responsible person - English: Alireza Sima Full name of responsible person - Persian: علیرضا سیما Street address - English: No. 144, 19th Alley, North Kargar Ave Street address - Persian: خیابان كارگر شمالي، كوچه 19، پلاك 144 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1439963553 Phone: +98 915 513 7188 Fax: Email: simaalireza@gmail.com Web page address:
Protocol summary
Study aim
Assessment of the non-inferiority of Infliximab (AryoGen) to Remicade (Janssen) in terms of efficacy in moderate to severe active UC
Design
phase III, randomized, two-armed, double-blind, parallel, active-controlled, non-inferiority clinical trial
Settings and conduct
260 Ulcerative colitis patients in multiple centers (Tehran, Shiraz, Mashhad, Isfahan, Sari, Rasht and Bandar-abbas), randomized, double-blind (patient, health-care provider and analyzer)
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18 to 65 years, moderate to severe active UC with indication for Infliximab therapy, ICF signing
Exclusion criteria:
Diagnosis of acute severe UC, Proctitis, indeterminate colitis, crohn’s disease, colonic obstruction, colonic mucosal dysplasia, adenomatous colonic polyps, TB, hepatitis B/C, HIV, history of toxic megacolon, C.diff, CMV within 30 days, herpes zoster, other autoimmune diseases, moderate to severe HF, active infection, history of severe fixed symptomatic stenosis, malignancy, demyelinating diseases, pregnancy or breast feeding, hypersensitivity, receiving protocol-prohibited treatments, abnormal lab tests, vaccinations, recent treatment with investigational agent, other conditions making subject enrollment inappropriate
Intervention groups
Intervention: Infliximab (AryoGen) 5 mg/kg, IV infusion, at day 0 and weeks 2, 6, 14, and 22
Control: Remicade (Janssen) 5 mg/kg, IV infusion, at day 0 and weeks 2, 6, 14, and 22
Main outcome variables
Percentage of patients achieving clinical response at week 8
General information
Reason for update
Minor changes were made to numbers 6, 15, 17, and 22 in the "Exclusion Criteria" section. In section 6, "ozanimod" was added. In section 15, the word "history" was added to toxic megacolon. Section 17 was changed to "CMV within the past 30 days" and in section 22, the word "severe" was removed.
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N36
Registration date:2025-03-21, 1404/01/01
Registration timing:prospective
Last update:2025-10-13, 1404/07/21
Update count:3
Registration date
2025-03-21, 1404/01/01
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-05-28, 1404/03/07
Expected recruitment end date
2027-07-31, 1406/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A phase 3, randomized, multicenter, double-blind, two-armed, parallel, active-controlled, Non-inferiority clinical trial to compare efficacy and safety of Infliximab (Infliximab produced by AryoGen Pharmed co) versus Remicade® (Infliximab produced by Janssen Immunology co.) in patients with active moderate to severe Ulcerative Colitis
Public title
Evaluation of non-inferiority of efficacy and safety of Infliximab (AryoGen) VS Remicade (Janssen) in UC
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18–65 years
Moderate to severe active UC
ICF signing
Exclusion criteria:
Active/latent TB
serious allergies to the formulation
Hepatitis B/C or HIV
Recent gastrointestinal surgery
indeterminate colitis or Crohn
Receiving biologics, JAK inhibitors or ozanimod
Tacrolimus and Cyclosporine within 4weeks
Proctitis
ASUC that requires hospitalization
Severe fixed symptomatic stenosis of intestine
Colonic obstruction or history of that within 6months
Having or history of colonic mucosal dysplasia
Adenomatous colonic polyps
Malignancy within 5years
History of Toxic megacolon
C.diff within 60days
CMV within 30days
Receiving IV corticosteroids within 14days
Herpes zoster within 8 weeks
History of demyelinating diseases
Diagnosis of other autoimmune-diseases
HF class III/IV
Abnormalities in laboratory data
Receiving live/attenuated vaccine less than 4weeks or planning to receive them
Pregnancy/ breastfeeding or planning to pregnancy in study
Active infection or history of hospitalization or receiving IV antibiotics within 8weeks or oral within 2weeks
Other disease or disorder which put the subject at risk
Treatment with any investigational agent in the past 4 weeks or passing less than five half-lives of agent
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization plan of the patients will be carried out centrally using an R-CRAN software version 4.2.1. Blocks (with the size 2 or 4) will be made using permuted block randomization for a total of 260 patients (1:1 allocation ratio). After the randomization procedure, a code will be allocated to each patient that will be used as a patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the first two letters of the first name, the first two letters of the surname) and three numbers (center code). Moreover, the described code is followed by a study unique identification code consisting of the first three letters of the generic name of the investigational product, respectively (IFX), and three numbers (corresponding to the randomization number), e.g., ABCD001IFX-001. The randomization number will be assigned in a consecutive way.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, subjects and the product administrators are blinded. The size of vials is different. For this purpose, subjects and administrator of the drug will be blinded by considering two nurses in each center: one nurse who opens the drug package and prepares the drug for injection, and another nurse who injects the drugs and will remain blind throughout the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central Building of TUMS, Ghods Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2025-02-19, 1403/12/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.612
Health conditions studied
1
Description of health condition studied
Ulcerative Colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Percentage of patients achieving clinical response based on MAYO score at week 8Clinical response: At least 3 points and 30% decrease from screening in the total MAYO Score; Decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
Timepoint
Screening, week 8
Method of measurement
Physician assessment and Endoscopy
Secondary outcomes
1
Description
Percentage of patients achieving clinical remission based on MAYO score at weeks 8 and 30Clinical remission: MAYO score of 2 points or lower, with no individual subscore exceeding 1 point.
Timepoint
Screening, week 8, week 30
Method of measurement
Physician assessment and Endoscopy
2
Description
Percentage of patients achieving clinical response based on MAYO Score at week 30
Timepoint
Screening, week 30
Method of measurement
Physician assessment and Endoscopy
3
Description
Percentage of patients achieving mucosal healing at weeks 8 and 30Mucosal healing: Absolute subscore for Endoscopy of 0 or 1.
Timepoint
Screening, week 8, week 30
Method of measurement
Endoscopy
4
Description
The changes of the IBDQ score at week 30 in comparison to week 0
Timepoint
Week 0, week 30
Method of measurement
IBDQ questionnaire
5
Description
Changes of Fecal calprotectin at week 30 in comparison to the screening
Timepoint
Screening, week 30
Method of measurement
Stool biochemistry test
6
Description
Percentage of patients with reduced dose of prednisolone at week 30 in comparison to screening
Timepoint
Screening, week 30
Method of measurement
Physician assessment
Intervention groups
1
Description
Intervention group: Infliximab (AryoGen Pharmed co., Iran), 5 mg/kg, intravenous infusion, at day 0 and weeks 2, 6, 14, and 22
Category
Treatment - Drugs
2
Description
Control group: Remicade® (Infliximab, Janssen Immunology co., Belgium) 5 mg/kg, intravenous infusion, at day 0 and weeks 2, 6, 14, and 22