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: Imam Khomeini Hospital
Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی
Full name of responsible person - English: Nasser Ebrahimi Daryani
Full name of responsible person - Persian: ناصر ابراهیمی دریانی
Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: nasere@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی
Full name of responsible person - English: Nasser Ebrahimi Daryani
Full name of responsible person - Persian: ناصر ابراهیمی دریانی
Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی امام خمینی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: nasere@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی Full name of responsible person - English: Nasser Ebrahimi Daryani Full name of responsible person - Persian: ناصر ابراهیمی دریانی Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی امام خمینی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6119 0000 Fax: Email: nasere@yahoo.com Web page address:
#2
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی
Full name of responsible person - English: Foroogh Alborzi Avanaki
Full name of responsible person - Persian: فروغ البرزی اوانکی
Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: alborzi.foroogh@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی
Full name of responsible person - English: Foroogh Alborzi Avanaki
Full name of responsible person - Persian: فروغ البرزی اوانکی
Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: alborzi.foroogh@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی Full name of responsible person - English: Foroogh Alborzi Avanaki Full name of responsible person - Persian: فروغ البرزی اوانکی Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستان امام خمینی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6119 0000 Fax: Email: alborzi.foroogh@gmail.com Web page address:
#3
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: 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: Next to the Faculty of Medicine, Karim Khan Zand Blvd
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: 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, Karim Khan Zand Blvd 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:
#4
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: 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: First Floor., Atieh Medical Building., 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: 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: First Floor., 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:
#5
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: 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: Emam RezaSalamat clinic of Alzahra Hospital Hospital Name of recruitment center - Persian: کلینیک سلامت بیمارستان امام رضاالزهرا Full name of responsible person - English: Ali BahariBabak Tamizifar Full name of responsible person - Persian: علی بهاریبابک تمیزیفر Street address - English: ٍEmam Reza Square.Soffeh Blvd, Ibn-e Sina AveShahid Keshvari High Way Street address - Persian: خیابان ابن سینابزرگراه شهید کشوری، میدان امام رضابلوار صفه City - English: MashhadIsfahan City - Persian: مشهداصفهان Province: Razavi KhorasanIsfehan Country: Iran (Islamic Republic of) Postal code: ٩١٣٧٩١٣٣١۶8174675731 Phone: +98 915 541 0429913 325 7859 Fax: Email: Bahariababaktamizifar@mums.ac.irgmail.com Web page address:
#6
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
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 clinicClinic of Alzahra Hospital Hospital Name of recruitment center - Persian: کلینیک سلامت بیمارستان الزهرا Full name of responsible person - English: Babak TamizifarHadi Abdollahi Full name of responsible person - Persian: بابک تمیزیفرهادی 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: +98 913 325 7859117 2760 Fax: Email: babaktamizifarHadi.abdolahi@gmail.comyahoo.com Web page address:
#7
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: 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: Salamat Clinic of AlzahraImam Khomeini Hospital Name of recruitment center - Persian: کلینیک سلامت 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: +98 913 117 276011 3304 4000 Fax: Email: Hadi.abdolahiiradj2001@yahoo.com Web page address:
#8
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:
#9
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: 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: Guilan Gastroenterology and Liver Specialist ClinicDr. Seyedhamid Moosavy clinic Name of recruitment center - Persian: کلینیک فوق تخصصی گوارش و کبد گیلاندکتر 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: ArsenUnits 207 & 208, 2nd Floor, Arjin Building, Imam Khomeini Ave.Beginning of Seyyed Jamal-eddin Asadabadi Blvd, Before Heshmat SquareAfter the Daraii Intersection Street address - Persian: خیابان امام خمینیبعد از سه راه دارایی، نرسیده به میدان حشمت،ابتدای بلوار سید جمال الدین اسد آبادی ساختمان آرسنآرژین طبقه دوم واحد 207 و 208 City - English: RashtBandarabbas City - Persian: رشتبندرعباس Province: GuilanHormozgan Country: Iran (Islamic Republic of) Postal code: 41369445017914690066 Phone: +98 911 131 3787917 763 5854 Fax: Email: ghanaieseyedhamid_moosavy@yahoo.com Web page address:
#10
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: 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: Dr. Seyedhamid Moosavy clinicShahid Beheshti Hospital Name of recruitment center - Persian: کلینیک دکتر سیدحمید موسویبیمارستان شهید بهشتی Full name of responsible person - English: Seyedhamid MoosavyJavad Shokri Full name of responsible person - Persian: سید حمید موسویجواد شکری Street address - English: Units 207 & 208, 2nd Floor, Arjin Building, Beginning of Seyyed Jamal-eddin Asadabadi Blvd, After the Daraii IntersectionSargord Ghasemi Ave Street address - Persian: بعد از سه راه دارایی، ابتدای بلوار سید جمال الدین اسد آبادی ساختمان آرژین طبقه دوم واحد 207 و 208خیابان سرگرد قاسمی City - English: BandarabbasBabol City - Persian: بندرعباسبابل Province: HormozganMazandaran Country: Iran (Islamic Republic of) Postal code: 79146900664716681451 Phone: +98 917 763 5854912 195 2294 Fax: Email: seyedhamid_moosavyjavadshokry@yahoo.comgmail.com Web page address:
#11
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: 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: Shahid Beheshti HospitalMasoud clinic Name of recruitment center - Persian: بیمارستان شهید بهشتیکلینیک مسعود Full name of responsible person - English: Javad ShokriAlireza Sima Full name of responsible person - Persian: جواد شکریعلیرضا سیما Street address - English: Sargord GhasemiNo. 144, 19th Alley, North Kargar Ave Street address - Persian: خیابان سرگرد قاسمیكارگر شمالي، كوچه 19، پلاك 144 City - English: BabolTehran City - Persian: بابلتهران Province: MazandaranTehran Country: Iran (Islamic Republic of) Postal code: 47166814511439963553 Phone: +98 912 195 2294915 513 7188 Fax: Email: javadshokrysimaalireza@gmail.com Web page address:
#12
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: Firoozgar General Hospital
Name of recruitment center - Persian: بيمارستان فيروزگر
Full name of responsible person - English: Amir Hosein Faraji
Full name of responsible person - Persian: امیرحسین فرجی
Street address - English: Firoozgar Hospital, Beh Afarin St., Valiasr Square, Tehran.
Street address - Persian: تهران، ميدان وليعصر (عج)، خيابان به آفرين، بيمارستان فيروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593748711
Phone: +98 912 825 1794
Fax:
Email: Amir.hfaraji6@gmail.com
Web page address:
Name of recruitment center - English: Masoud clinicFiroozgar General Hospital Name of recruitment center - Persian: کلینیک مسعودبيمارستان فيروزگر Full name of responsible person - English: Alireza SimaAmir Hosein Faraji Full name of responsible person - Persian: علیرضا سیماامیرحسین فرجی Street address - English: No. 144Firoozgar Hospital, 19th AlleyBeh Afarin St., North Kargar AveValiasr Square, Tehran. Street address - Persian: خیابان كارگر شماليتهران، كوچه 19ميدان وليعصر (عج)، پلاك 144خيابان به آفرين، بيمارستان فيروزگر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14399635531593748711 Phone: +98 915 513 7188912 825 1794 Fax: Email: simaalirezaAmir.hfaraji6@gmail.com Web page address:
#13
Name of recruitment center - English: Salamat Medical Complex
Name of recruitment center - Persian: مجتمع پزشکی سلامت
Full name of responsible person - English: Mohammad Hossein Somi
Full name of responsible person - Persian: محمد حسین صومی
Street address - English: Salamat Medical Complex, Eighth Floor, Pishghadam Bridge, Middle Ringroad, Tabriz
Street address - Persian: تبریز، کمربندی میانی، پل پیشقدم، طبقه هشتم، مجتمع پزشکی سلامت
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5165741651
Phone: +98 914 313 6460
Fax:
Email: Mhosseinsina@yahoo.com
Web page address:
Name of recruitment center - English: Salamat Medical Complex Name of recruitment center - Persian: مجتمع پزشکی سلامت Full name of responsible person - English: Mohammad Hossein Somi Full name of responsible person - Persian: محمد حسین صومی Street address - English: Salamat Medical Complex, Eighth Floor, Pishghadam Bridge, Middle Ringroad, Tabriz Street address - Persian: تبریز، کمربندی میانی، پل پیشقدم، طبقه هشتم، مجتمع پزشکی سلامت City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5165741651 Phone: +98 914 313 6460 Fax: Email: Mhosseinsina@yahoo.com Web page address:
#14
Name of recruitment center - English: Mehregan Hospital
Name of recruitment center - Persian: بیمارستان مهرگان
Full name of responsible person - English: Mohammad javad zahedi
Full name of responsible person - Persian: محمد جواد زاهدی
Street address - English: Mehregan Hospital, Kamyab St, Kerman
Street address - Persian: کرمان، خیابان شهید کامیاب، بیمارستان مهرگان
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7614613191
Phone: +98 913 140 1208
Fax:
Email: Zahedi@kmu.ac.ir
Web page address:
Name of recruitment center - English: Mehregan Hospital Name of recruitment center - Persian: بیمارستان مهرگان Full name of responsible person - English: Mohammad javad zahedi Full name of responsible person - Persian: محمد جواد زاهدی Street address - English: Mehregan Hospital, Kamyab St, Kerman Street address - Persian: کرمان، خیابان شهید کامیاب، بیمارستان مهرگان City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7614613191 Phone: +98 913 140 1208 Fax: Email: Zahedi@kmu.ac.ir Web page address:
#15
Name of recruitment center - English: Dr. Bashiri Gastroenterology Clinic
Name of recruitment center - Persian: کلینیک گوارش دکتر بشیری
Full name of responsible person - English: Homayoon Bashiri
Full name of responsible person - Persian: همایون بشیری
Street address - English: Dr. Bashiri Gastroenterology Clinic, Day Building, Haj Mohammad Taghi Esfahani Street, Municipality Parking Lot, Kermanshah
Street address - Persian: کرمانشاه، پارکینگ شهرداری، خیابان حاج محمدتقی اصفهانی، ساختمان دی، کلینیک گوارش دکتر بشیری
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6714636554
Phone: +98 918 131 0389
Fax:
Email: hbashirimd@gmail.com
Web page address:
Name of recruitment center - English: Dr. Bashiri Gastroenterology Clinic Name of recruitment center - Persian: کلینیک گوارش دکتر بشیری Full name of responsible person - English: Homayoon Bashiri Full name of responsible person - Persian: همایون بشیری Street address - English: Dr. Bashiri Gastroenterology Clinic, Day Building, Haj Mohammad Taghi Esfahani Street, Municipality Parking Lot, Kermanshah Street address - Persian: کرمانشاه، پارکینگ شهرداری، خیابان حاج محمدتقی اصفهانی، ساختمان دی، کلینیک گوارش دکتر بشیری City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6714636554 Phone: +98 918 131 0389 Fax: Email: hbashirimd@gmail.com Web page address:
#16
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی(ره)
Full name of responsible person - English: Arash Mir Oliyaee
Full name of responsible person - Persian: آرش میراولیایی
Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.
Street address - Persian: تهران، بلوار کشاورز، مجتمع بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: Arashmiroliaee53@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی(ره) Full name of responsible person - English: Arash Mir Oliyaee Full name of responsible person - Persian: آرش میراولیایی Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran. Street address - Persian: تهران، بلوار کشاورز، مجتمع بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6119 0000 Fax: Email: Arashmiroliaee53@gmail.com Web page address:
#17
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی(ره)
Full name of responsible person - English: Reza Taslimi
Full name of responsible person - Persian: رضا تسلیمی
Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.
Street address - Persian: تهران، بلوار کشاورز، مجتمع بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: Taslimir@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی(ره) Full name of responsible person - English: Reza Taslimi Full name of responsible person - Persian: رضا تسلیمی Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran. Street address - Persian: تهران، بلوار کشاورز، مجتمع بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6119 0000 Fax: Email: Taslimir@yahoo.com Web page address:
#18
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی(ره)
Full name of responsible person - English: Behshad Pazooki
Full name of responsible person - Persian: بهشاد پازوکی
Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.
Street address - Persian: تهران، بلوار کشاورز، مجتمع بیمارستان امام خمینی(ره)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: Behshad.pazooki@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Name of recruitment center - Persian: مجتمع بیمارستان امام خمینی(ره) Full name of responsible person - English: Behshad Pazooki Full name of responsible person - Persian: بهشاد پازوکی Street address - English: Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran. Street address - Persian: تهران، بلوار کشاورز، مجتمع بیمارستان امام خمینی(ره) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6119 0000 Fax: Email: Behshad.pazooki@yahoo.com Web page address:
#19
Name of recruitment center - English: Kourosh Clinic
Name of recruitment center - Persian: کلینیک کوروش
Full name of responsible person - English: Homeira Ommati
Full name of responsible person - Persian: حمیرا امتی
Street address - English: Korosh Clinic, First Floor, Benyamin Building, Corner of Parastar 7, Ahmadabad, Mashhad
Street address - Persian: مشهد، احمدآباد، نبش پرستار هفت، ساختمان بنیامین، طبقه اول، کلینیک کوروش
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176694152
Phone: +98 915 318 6759
Fax:
Email: dr.homeira.ommati@gmail.com
Web page address:
Name of recruitment center - English: Kourosh Clinic Name of recruitment center - Persian: کلینیک کوروش Full name of responsible person - English: Homeira Ommati Full name of responsible person - Persian: حمیرا امتی Street address - English: Korosh Clinic, First Floor, Benyamin Building, Corner of Parastar 7, Ahmadabad, Mashhad Street address - Persian: مشهد، احمدآباد، نبش پرستار هفت، ساختمان بنیامین، طبقه اول، کلینیک کوروش City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9176694152 Phone: +98 915 318 6759 Fax: Email: dr.homeira.ommati@gmail.com Web page address:
#20
Name of recruitment center - English: Kourosh Clinic
Name of recruitment center - Persian: کلینیک کوروش
Full name of responsible person - English: Mohammad Reza Farzanehfar
Full name of responsible person - Persian: محمدرضا فرزانه فر
Street address - English: Korosh Clinic, First Floor, Benyamin Building, Corner of Parastar 7, Ahmadabad, Mashhad
Street address - Persian: مشهد، احمدآباد، نبش پرستار هفت، ساختمان بنیامین، طبقه اول، کلینیک کوروش
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176694152
Phone: +98 915 508 3486
Fax:
Email: farzanehfm84@gmail.com
Web page address:
Name of recruitment center - English: Kourosh Clinic Name of recruitment center - Persian: کلینیک کوروش Full name of responsible person - English: Mohammad Reza Farzanehfar Full name of responsible person - Persian: محمدرضا فرزانه فر Street address - English: Korosh Clinic, First Floor, Benyamin Building, Corner of Parastar 7, Ahmadabad, Mashhad Street address - Persian: مشهد، احمدآباد، نبش پرستار هفت، ساختمان بنیامین، طبقه اول، کلینیک کوروش City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9176694152 Phone: +98 915 508 3486 Fax: Email: farzanehfm84@gmail.com Web page address:
#21
Name of recruitment center - English: Dr Faghihi Hospital
Name of recruitment center - Persian: بیمارستان دکتر فقیهی
Full name of responsible person - English: Ali Shahsavari
Full name of responsible person - Persian: علی شهسواری گوغری
Street address - English: Dr Faghihi Hospital, Next to the Faculty of Medicine, Karim Khan Zand Boulevard, Shiraz
Street address - Persian: شیراز، بلوار کریم خان زند، جنب دانشکده پزشکی، بیمارستان دکتر فقیهی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: ۷۱۳۴۸۴۶۱۱۴
Phone: +98 917 913 5108
Fax:
Email: alishahsavari076@gmail.com
Web page address:
Name of recruitment center - English: Dr Faghihi Hospital Name of recruitment center - Persian: بیمارستان دکتر فقیهی Full name of responsible person - English: Ali Shahsavari Full name of responsible person - Persian: علی شهسواری گوغری Street address - English: Dr Faghihi Hospital, Next to the Faculty of Medicine, Karim Khan Zand Boulevard, Shiraz Street address - Persian: شیراز، بلوار کریم خان زند، جنب دانشکده پزشکی، بیمارستان دکتر فقیهی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: ۷۱۳۴۸۴۶۱۱۴ Phone: +98 917 913 5108 Fax: Email: alishahsavari076@gmail.com Web page address:
#22
Name of recruitment center - English: Shariati Hospital of Isfahan
Name of recruitment center - Persian: بیمارستان شریعتی اصفهان
Full name of responsible person - English: Hamid Mohajer
Full name of responsible person - Persian: حمید مهاجر
Street address - English: Shariati Hospital of Isfahan, First Taj al-Din Alley, Taj al-Din Alley, Sichan, Chahar Bagh Bala, Isfahan
Street address - Persian: اصفهان، سیچان چهار باغ بالا، کوچه تاج الدین اول، کوچه تاج الدین، بیمارستان شریعتی اصفهان
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8173745384
Phone: +98 913 327 7156
Fax:
Email: hamidmohajermd@gmail.com
Web page address:
Name of recruitment center - English: Shariati Hospital of Isfahan Name of recruitment center - Persian: بیمارستان شریعتی اصفهان Full name of responsible person - English: Hamid Mohajer Full name of responsible person - Persian: حمید مهاجر Street address - English: Shariati Hospital of Isfahan, First Taj al-Din Alley, Taj al-Din Alley, Sichan, Chahar Bagh Bala, Isfahan Street address - Persian: اصفهان، سیچان چهار باغ بالا، کوچه تاج الدین اول، کوچه تاج الدین، بیمارستان شریعتی اصفهان City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8173745384 Phone: +98 913 327 7156 Fax: Email: hamidmohajermd@gmail.com Web page address:
#23
Name of recruitment center - English: Imam Ali Hospital
Name of recruitment center - Persian: بیمارستان امام علی(ع)
Full name of responsible person - English: Reyhaneh Jafarshad
Full name of responsible person - Persian: ریحانه جعفرشاد
Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province
Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع)
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3154686695
Phone: +98 911 136 4161
Fax:
Email: shad.reyhan@gmail.com
Web page address:
Name of recruitment center - English: Imam Ali Hospital Name of recruitment center - Persian: بیمارستان امام علی(ع) Full name of responsible person - English: Reyhaneh Jafarshad Full name of responsible person - Persian: ریحانه جعفرشاد Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع) City - English: Karaj City - Persian: کرج Province: Alborz Country: Iran (Islamic Republic of) Postal code: 3154686695 Phone: +98 911 136 4161 Fax: Email: shad.reyhan@gmail.com Web page address:
#24
Name of recruitment center - English: Imam Ali Hospital
Name of recruitment center - Persian: بیمارستان امام علی(ع)
Full name of responsible person - English: Mohsen Rajabnia Chenari
Full name of responsible person - Persian: محسن رجب نیا چناری
Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province
Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع)
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3154686695
Phone: +98 935 771 9022
Fax:
Email: Drrajabnia@gmail.com
Web page address:
Name of recruitment center - English: Imam Ali Hospital Name of recruitment center - Persian: بیمارستان امام علی(ع) Full name of responsible person - English: Mohsen Rajabnia Chenari Full name of responsible person - Persian: محسن رجب نیا چناری Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع) City - English: Karaj City - Persian: کرج Province: Alborz Country: Iran (Islamic Republic of) Postal code: 3154686695 Phone: +98 935 771 9022 Fax: Email: Drrajabnia@gmail.com Web page address:
#25
Name of recruitment center - English: Imam Ali Hospital
Name of recruitment center - Persian: بیمارستان امام علی(ع)
Full name of responsible person - English: Roham Gholami
Full name of responsible person - Persian: رهام غلامی
Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province
Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع)
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3154686695
Phone: +98 912 298 9204
Fax:
Email: dr_rgholami@yahoo.com
Web page address:
Name of recruitment center - English: Imam Ali Hospital Name of recruitment center - Persian: بیمارستان امام علی(ع) Full name of responsible person - English: Roham Gholami Full name of responsible person - Persian: رهام غلامی Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع) City - English: Karaj City - Persian: کرج Province: Alborz Country: Iran (Islamic Republic of) Postal code: 3154686695 Phone: +98 912 298 9204 Fax: Email: dr_rgholami@yahoo.com Web page address:
#26
Name of recruitment center - English: Imam Ali Hospital
Name of recruitment center - Persian: بیمارستان امام علی(ع)
Full name of responsible person - English: Amir Abbas Vaezi
Full name of responsible person - Persian: امیرعباس واعظی
Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province
Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع)
City - English: Karaj
City - Persian: کرج
Province: Alborz
Country: Iran (Islamic Republic of)
Postal code: 3154686695
Phone: +98 912 361 5071
Fax:
Email: Avaezi60@gmail.com
Web page address:
Name of recruitment center - English: Imam Ali Hospital Name of recruitment center - Persian: بیمارستان امام علی(ع) Full name of responsible person - English: Amir Abbas Vaezi Full name of responsible person - Persian: امیرعباس واعظی Street address - English: Imam Ali Hospital, Azimieh, Resalat Three-Way, Karaj, Alborz Province Street address - Persian: البرز، كرج، سه راه رسالت، عظيميه، بیمارستان امام علی(ع) City - English: Karaj City - Persian: کرج Province: Alborz Country: Iran (Islamic Republic of) Postal code: 3154686695 Phone: +98 912 361 5071 Fax: Email: Avaezi60@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:2026-02-02, 1404/11/13
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