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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Protocol summary
phase III, randomized, two-armed, double-blind, parallel, active-controlled, non-inferiority clinical trial
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)
phase III260 Ulcerative colitis patients in multiple centers (Tehran, Shiraz, Mashhad, Isfahan, Sari, Rasht and Bandar-abbas), randomized, two-armed, double-blind (patient, parallel, activehealth-controlled, non-inferiority clinical trialcare provider and analyzer)
کارآزمایی بالینی فاز III، تصادفی، دوبازو، دوسوکور، موازی، کنترلفعال، non-inferiority
260 بیمار کولیت اولسراتیو در چند مرکز (تهران، شیراز، مشهد، اصفهان، ساری، رشت و بندرعباس)، تصادفیشده، دوسوکور (بیمار، کادر درمان و آنالیزور)
کارآزمایی بالینی فاز III260 بیمار کولیت اولسراتیو در چند مرکز (تهران، شیراز، مشهد، اصفهان، ساری، رشت و بندرعباس)، تصادفی، دوبازوشده، دوسوکور (بیمار، موازی، کنترلفعال، non-inferiorityکادر درمان و آنالیزور)
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, toxic megacolon, C.diff, CMV, herpes zoster, other autoimmune diseases, 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
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
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
شرایط ورود:
18 تا 65 سال، UC فعال و متوسط تا شدید کاندید دریافت اینفلیکسیمب، امضای رضایتنامه
شرایط عدمورود:
ابتلا به فرم حاد یا محدود به رکتوم UC، Indeterminate Colitis، Crohn’s disease، انسداد کولون، Colonic Mucosal Dysplasia، پولیپ آدنوماتوز کولون، سل، هپاتیت B/C،HIV، توکسیک مگاکولون، C.diff، CMV، هرپس زوستر، سایر بیماریهای خودایمنی، نارسایی قلبی شدید، عفونت فعال، سابقه Severe Fixed Symptomatic Stenosis، بدخیمی، بیماری دمیلینهکننده، بارداری، شیردهی، حساسیت، درمانهای ممنوعه پروتکل، ناهنجاریهای آزمایشگاهی مطابق پروتکل، دریافت واکسن زنده، دریافت اخیر ماده تحقیقاتی، سایر شرایطی که داوطلب را برای کارآزمایی نامناسب می کند.
شرایط ورود:
18 تا 65 سال، UC فعال و متوسط تا شدید کاندید دریافت اینفلیکسیمب، امضای رضایتنامه
شرایط عدمورود:
ابتلا به فرم حاد یا محدود به رکتوم UC، Indeterminate Colitis، Crohn’s disease، انسداد کولون، Colonic Mucosal Dysplasia، پولیپ آدنوماتوز کولون، سل، هپاتیت B/C،HIV، سابقه توکسیک مگاکولون، 30CMV روز پیش، C diff، هرپس زوستر، سایر بیماریهای خودایمنی، نارسایی قلبی متوسط تا شدید، عفونت فعال، سابقه Severe Fixed Symptomatic Stenosis، بدخیمی، بیماری دمیلینهکننده، بارداری، شیردهی، حساسیت، درمانهای ممنوعه پروتکل، ناهنجاریهای آزمایشگاهی مطابق پروتکل، دریافت واکسن زنده، دریافت اخیر ماده تحقیقاتی، سایر شرایطی که داوطلب را برای کارآزمایی نامناسب می کند.
شرایط ورود: 18 تا 65 سال، UC فعال و متوسط تا شدید کاندید دریافت اینفلیکسیمب، امضای رضایتنامه شرایط عدمورود: ابتلا به فرم حاد یا محدود به رکتوم UC، Indeterminate Colitis، Crohn’s disease، انسداد کولون، Colonic Mucosal Dysplasia، پولیپ آدنوماتوز کولون، سل، هپاتیت B/C،HIV، سابقه توکسیک مگاکولون، C.diff30CMV روز پیش، CMVC diff، هرپس زوستر، سایر بیماریهای خودایمنی، نارسایی قلبی متوسط تا شدید، عفونت فعال، سابقه Severe Fixed Symptomatic Stenosis، بدخیمی، بیماری دمیلینهکننده، بارداری، شیردهی، حساسیت، درمانهای ممنوعه پروتکل، ناهنجاریهای آزمایشگاهی مطابق پروتکل، دریافت واکسن زنده، دریافت اخیر ماده تحقیقاتی، سایر شرایطی که داوطلب را برای کارآزمایی نامناسب می کند.
مداخله: انفوزیون اینفلیکسیمب (آریوژن) با دوز mg/kg 5 در روز 0، هفتههای 2، 6، 14 و 22.
کنترل: انفوزیون رمیکید (جانسن) با دوز mg/kg 5 در روز 0، هفتههای 2، 6، 14 و 22 .
مداخله: انفوزیون اینفلیکسیمب (آریوژن) با دوز 5 میلی گرم برای هر کیلوگرم در روز 0، هفتههای 2، 6، 14 و 22.
کنترل: انفوزیون رمیکید (جانسن) با دوز 5 میلی گرم برای هر کیلوگرم در روز 0، هفتههای 2، 6، 14 و 22 .
مداخله: انفوزیون اینفلیکسیمب (آریوژن) با دوز mg/kg 5 میلی گرم برای هر کیلوگرم در روز 0، هفتههای 2، 6، 14 و 22. کنترل: انفوزیون رمیکید (جانسن) با دوز mg/kg 5 میلی گرم برای هر کیلوگرم در روز 0، هفتههای 2، 6، 14 و 22 .
General information
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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.
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.
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تغییرات جزئی در شماره های 6، 15، 17 و 22 بخش "معیارهای عدم ورود" اعمال شد. در شماره 6 معیارهای عدم ورود "اوزانیمود" اضافه شد. در شماره 15معیارهای عدم ورود، کلمه "سابقه" به توکسیک مگاکولون اضافه شد. شماره 17 به "CMV طی 30روز پیش" تغییر یافت و در شماره 22 کلمه severe حذف شد.
تغییرات جزئی در شماره های 6، 15، 17 و 22 بخش "معیارهای عدم ورود" اعمال شد. در شماره 6 معیارهای عدم ورود "اوزانیمود" اضافه شد. در شماره 15معیارهای عدم ورود، کلمه "سابقه" به توکسیک مگاکولون اضافه شد. شماره 17 به "CMV طی 30روز پیش" تغییر یافت و در شماره 22 کلمه severe حذف شد.
Active/latent TB
serious allergies to the formulation
Hepatitis B/C or HIV
Recent gastrointestinal surgery
indeterminate colitis or Crohn
Receiving biologics and JAK inhibitors
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
Toxic megacolon
C.diff within 60days
History or diagnosis of CMV
Receiving IV corticosteroids within 14days
Herpes zoster within 8 weeks
History of demyelinating diseases
Diagnosis of other autoimmune-diseases
Severe 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
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
Active/latent TB serious allergies to the formulation Hepatitis B/C or HIV Recent gastrointestinal surgery indeterminate colitis or Crohn Receiving biologics and, 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 History or diagnosis of CMV within 30days Receiving IV corticosteroids within 14days Herpes zoster within 8 weeks History of demyelinating diseases Diagnosis of other autoimmune-diseases Severe 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
سل فعال/نهفته
واکنشهای حساسیتی به فرمولاسیون
هپاتیت B/C یا HIV
جراحی گوارشی اخیر
Indeterminate Colitis یاCrohn
دریافت بیولوژیک و JAK Inhibitors
دریافت سیکلوسپورین و تاکرولیموس 4 هفته پیش
UC محدود به رکتوم
ASUC نیازمند بستری
Severe Fixed Symptomatic Stenosis روده
انسداد کولون یا سابقه آن طی 6ماه اخیر
Colonic Mucosal Dysplasia یا سابقه آن
پولیپهای آدنوماتوز کولون
سابقه بدخیمی در 5سال پیش
توکسیک مگاکولون
C.diff طی 60روز پیش
سابقه یا ابتلا CMV
کورتیکواستروئید وریدی طی 2هفته پیش
هرپس زوستر در 8 هفته اخیر
سابقه بیماریهای دمیلینهکننده
تشخیص سایر بیماریهای خودایمنی
نارسایی قلبی کلاس III/IV
نتایج آزمایشگاهی خارج از محدوده تعریفشده
دریافت واکسنهای زنده ضعیفشده در 4هفته اخیر یا قصد تزریقشان
بارداری/شیردهی یا قصد بارداری در مطالعه
عفونت فعال یا سابقه بستریشدن یا درمان با آنتیبیوتیکهای تزریقی در 8هفته پیش یا خوراکی در 2هفته پیش
هر دلیل دیگری که یک بیمار را نامناسب نشان دهد
مشارکت در هر مطالعه دیگر/دریافت فرآورده تحقیقاتی طی 4 هفته پیش یا عدم گذشت 5 نیمه عمر از دارو
سل فعال/نهفته
واکنشهای حساسیتی به فرمولاسیون
هپاتیت B/C یا HIV
جراحی گوارشی اخیر
Indeterminate Colitis یاCrohn
دریافت بیولوژیک ، JAK Inhibitors یا اوزانیمود
دریافت سیکلوسپورین و تاکرولیموس 4 هفته پیش
UC محدود به رکتوم
ASUC نیازمند بستری
Severe Fixed Symptomatic Stenosis روده
انسداد کولون یا سابقه آن طی 6ماه اخیر
Colonic Mucosal Dysplasia یا سابقه آن
پولیپهای آدنوماتوز کولون
سابقه بدخیمی در 5سال پیش
سابقه توکسیک مگاکولون
C.diff طی 60روز پیش
CMV طی 30روز پیش
کورتیکواستروئید وریدی طی 2هفته پیش
هرپس زوستر در 8 هفته اخیر
سابقه بیماریهای دمیلینهکننده
تشخیص سایر بیماریهای خودایمنی
نارسایی قلبی کلاس III/IV
نتایج آزمایشگاهی خارج از محدوده تعریفشده
دریافت واکسنهای زنده ضعیفشده در 4هفته اخیر یا قصد تزریقشان
بارداری/شیردهی یا قصد بارداری در مطالعه
عفونت فعال یا سابقه بستریشدن یا درمان با آنتیبیوتیکهای تزریقی در 8هفته پیش یا خوراکی در 2هفته پیش
هر دلیل دیگری که یک بیمار را نامناسب نشان دهد
مشارکت در هر مطالعه دیگر/دریافت فرآورده تحقیقاتی طی 4 هفته پیش یا عدم گذشت 5 نیمه عمر از دارو
سل فعال/نهفته واکنشهای حساسیتی به فرمولاسیون هپاتیت B/C یا HIV جراحی گوارشی اخیر Indeterminate Colitis یاCrohn دریافت بیولوژیک و، JAK Inhibitors یا اوزانیمود دریافت سیکلوسپورین و تاکرولیموس 4 هفته پیش UC محدود به رکتوم ASUC نیازمند بستری Severe Fixed Symptomatic Stenosis روده انسداد کولون یا سابقه آن طی 6ماه اخیر Colonic Mucosal Dysplasia یا سابقه آن پولیپهای آدنوماتوز کولون سابقه بدخیمی در 5سال پیش سابقه توکسیک مگاکولون C.diff طی 60روز پیش سابقه یا ابتلا CMV طی 30روز پیش کورتیکواستروئید وریدی طی 2هفته پیش هرپس زوستر در 8 هفته اخیر سابقه بیماریهای دمیلینهکننده تشخیص سایر بیماریهای خودایمنی نارسایی قلبی کلاس III/IV نتایج آزمایشگاهی خارج از محدوده تعریفشده دریافت واکسنهای زنده ضعیفشده در 4هفته اخیر یا قصد تزریقشان بارداری/شیردهی یا قصد بارداری در مطالعه عفونت فعال یا سابقه بستریشدن یا درمان با آنتیبیوتیکهای تزریقی در 8هفته پیش یا خوراکی در 2هفته پیش هر دلیل دیگری که یک بیمار را نامناسب نشان دهد مشارکت در هر مطالعه دیگر/دریافت فرآورده تحقیقاتی طی 4 هفته پیش یا عدم گذشت 5 نیمه عمر از دارو
Secondary outcomes
#1
Changes of Fecal calprotectin from week 0 up to week 30
Changes of Fecal calprotectin at week 30 in comparison to the screening
Changes of Fecal calprotectin from week 0 up toat week 30 in comparison to the screening
سنجش تغییرات Fecal Calprotectin در هفته 30 در مقایسه با هفته صفر
سنجش تغییرات Fecal Calprotectin در هفته 30 در مقایسه با غربالگری
سنجش تغییرات Fecal Calprotectin در هفته 30 در مقایسه با هفته صفرغربالگری
Week 0, week 30
Screening, week 30
Week 0Screening, week 30
هفته صفر، هفته 30
غربالگری، هفته 30
هفته صفرغربالگری، هفته 30
Recruitment centers
#1
Name of recruitment center - English: Alzahra Hospital
Name of recruitment center - Persian: بیمارستان الزهرا
Full name of responsible person - English: Peyman Adibi
Full name of responsible person - Persian: پیمان ادیبی سده
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: peyman.adibi@gmail.com
Web page address:
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: Alzahra Hospital Name of recruitment center - Persian: بیمارستان الزهرا Full name of responsible person - English: Peyman AdibiBabak Tamizifar Full name of responsible person - Persian: پیمان ادیبی سدهبابک 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: peyman.adibibabaktamizifar@gmail.com Web page address:
#2
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: 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: Alzahra Hospital Name of recruitment center - Persian: بیمارستان الزهرا Full name of responsible person - English: Babak TamizifarMohammad Hassan Emami Najafi Dehkordi Full name of responsible person - Persian: بابک تمیزیفرمحمدحسن 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: babaktamizifarmh.emami1338@gmail.com Web page address:
#3
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: 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: Alzahra Hospital Name of recruitment center - Persian: 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 0000 Fax: Email: mh.emami1338Hadi.abdolahi@gmail.comyahoo.com Web page address:
#4
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:
#5
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: 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: Imam KhomeiniRazi Hospital Name of recruitment center - Persian: بیمارستان امام خمینیمرکز آموزشی درمانی رازی Full name of responsible person - English: Iraj MalekiFariborz Mansour Ghanaei Full name of responsible person - Persian: ایرج ملکیفریبرز منصور قناعی Street address - English: Razi AveSardar Jangal Street, Valie-Asr BlvdRasht, Iran Street address - Persian: بلوار ولیعصررشت، خیابان سردار جنگل، مرکز آموزشی درمانی رازی City - English: SariRasht City - Persian: ساریرشت Province: MazandaranGuilan Country: Iran (Islamic Republic of) Postal code: 48166 331314144895655 Phone: +98 11 3304 400013 3354 1001 Fax: Email: iradj2001ghanaie@yahoo.com Web page address:
#6
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: 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: RaziPayambar Azam Hospital Name of recruitment center - Persian: مرکز آموزشی درمانی رازیبیمارستان پیامبر اعظم 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 Street, Rasht, IranJomhori Eslami Blvd Street address - Persian: رشت، خیابان سردار جنگل، مرکز آموزشی درمانی رازیبلوار جمهوری اسلامی City - English: RashtBandarabbas City - Persian: رشتبندرعباس Province: GuilanHormozgan Country: Iran (Islamic Republic of) Postal code: 41448956557919915519 Phone: +98 13 3354 100176 3334 7000 Fax: Email: ghanaieseyedhamid_moosavy@yahoo.com Web page address:
#7
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: 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:
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:2025-06-22, 1404/04/01
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