History
# Registration date Revision Id
4 2026-01-27, 1404/11/07 371368
3 2025-10-04, 1404/07/12 358856
2 2025-06-15, 1404/03/25 344971
1 2025-03-21, 1404/01/01 334293
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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:
    #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:
    #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:
    #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:
    #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:
    #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:
    #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:
    #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:
    #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:
    #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:
    #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:
    #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:
    #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:

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
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Nasser Ebrahimi Daryani
Street address
Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
nasere@yahoo.com

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Foroogh Alborzi Avanaki
Street address
Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
alborzi.foroogh@gmail.com

3

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Taher
Street address
Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Tahermdir@gmail.com

4

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Homayoun Vahedi Tafreshi
Street address
Ale-Ahmad Junc, Karegar Ave,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
dr_vahedi@yahoo.com

5

Recruitment center
Name of recruitment center
Masoud clinic
Full name of responsible person
Amir Anoushirvani
Street address
No. 144, 19th Alley, North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439963553
Phone
+98 917 316 0616
Email
amiranush@gmail.com

6

Recruitment center
Name of recruitment center
Masoud Clinic
Full name of responsible person
Marjan Mokhtare
Street address
No. 144, Alley 19., North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439963553
Phone
+98 911 156 8597
Email
marjanmokhtare@yahoo.com

7

Recruitment center
Name of recruitment center
Professor Shahram Aghah Gastroenterology, Hepatology, and Endoscopy Specialty Clinic
Full name of responsible person
Shahram Agah
Street address
Unit 24, No. 1, 9th Alley, North Side of Kaj Square (Shahid Tehrani Moghadam), Saadat Abad
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 912 327 8615
Email
shahramagah@gmail.com

8

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Shabnam Shahrokh
Street address
Araabi St., ؛Yaman Ave., Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2293 7031
Email
shabnamshahrokh@gmail.com

9

Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Kamran Bagheri Lankarani
Street address
Karim Khan Zand Blvd, Next to the Faculty of Medicine
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 917 118 4083
Email
kblankarani@gmail.com

10

Recruitment center
Name of recruitment center
Pazh Clinic
Full name of responsible person
Hasan Vosoughinia
Street address
Atieh Medical Building., First Floor., Before Tak Complex., Between Dastgheib 33 and 35., Khayyam Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9185811111
Phone
+98 915 310 0263
Email
vosoghiniah@mums.ac.ir

11

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ali Bahari
Street address
ٍEmam Reza Square., Ibn-e Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 915 541 0429
Email
Baharia@mums.ac.ir

12

Recruitment center
Name of recruitment center
Salamat clinic of Alzahra Hospital Hospital
Full name of responsible person
Babak Tamizifar
Street address
Soffeh Blvd, Shahid Keshvari High Way
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 325 7859
Email
babaktamizifar@gmail.com

13

Recruitment center
Name of recruitment center
Salamat Clinic of Alzahra Hospital
Full name of responsible person
Hadi Abdollahi
Street address
Soffeh Blvd, Shahid Keshvari High Way
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 117 2760
Email
Hadi.abdolahi@yahoo.com

14

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Iraj Maleki
Street address
Razi Ave, Valie-Asr Blvd,
City
Sari
Province
Mazandaran
Postal code
48166 33131
Phone
+98 11 3304 4000
Email
iradj2001@yahoo.com

15

Recruitment center
Name of recruitment center
Guilan Gastroenterology and Liver Specialist Clinic
Full name of responsible person
Fariborz Mansour Ghanaei
Street address
Arsen Building, Imam Khomeini Ave., Before Heshmat Square
City
Rasht
Province
Guilan
Postal code
4136944501
Phone
+98 911 131 3787
Email
ghanaie@yahoo.com

16

Recruitment center
Name of recruitment center
Dr. Seyedhamid Moosavy clinic
Full name of responsible person
Seyedhamid Moosavy
Street address
Units 207 & 208, 2nd Floor, Arjin Building, Beginning of Seyyed Jamal-eddin Asadabadi Blvd, After the Daraii Intersection
City
Bandarabbas
Province
Hormozgan
Postal code
7914690066
Phone
+98 917 763 5854
Email
seyedhamid_moosavy@yahoo.com

17

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Javad Shokri
Street address
Sargord Ghasemi Ave
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 912 195 2294
Email
javadshokry@gmail.com

18

Recruitment center
Name of recruitment center
Masoud clinic
Full name of responsible person
Alireza Sima
Street address
No. 144, 19th Alley, North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439963553
Phone
+98 915 513 7188
Email
simaalireza@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
AryoGen Pharmed Company
Full name of responsible person
Mohammad Saffarioun
Street address
No. 140, 24th Km Tehran-Karaj Makhsous road
City
Karaj
Province
Alborz
Postal code
3164819712
Phone
+98 26 3610 6480
Email
contact@aryogen.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AryoGen Pharmed Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Orchid Pharmed Co.
Full name of responsible person
Hamidreza Kafi
Position
Medical Department Manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 42, Attar St., Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
Kafi.H@orchidpharmed.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Nasser Ebrahimi Daryani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and Hepatology
Street address
Keshavarz Bldv, Imam Khomeini Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 912 923 2594
Email
nasere@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Orchid Pharmed Co.
Full name of responsible person
Hamidreza Kafi
Position
Medical Department Manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 42, Attar St., Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Email
Kafi.H@orchidpharmed.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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