96. Crohn disease
2,209 clinical trials,   1,276 drugs   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
24 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2031200117
01/09/202011/09/2020A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohns DiseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohns Disease Crohns DiseaseBiological: CT-P13 SC (Infliximab)
Other: Placebo SC
Ishida TetsuyaCelltrionRecruiting>= 18age old<= 75age oldBoth600Phase 3Austria;Bulgaria;Croatia;Japan;US;Latvia;Czech Republic;France;Poland;Germany;Greece;Hungary;Spain
2EUCTR2019-001087-30-AT
(EUCTR)
28/11/201912/09/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan
3EUCTR2019-001087-30-HR
(EUCTR)
11/11/201917/01/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
4EUCTR2019-001087-30-DE
(EUCTR)
31/10/201901/07/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
5EUCTR2019-001087-30-BG
(EUCTR)
30/10/201924/10/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03945019
(ClinicalTrials.gov)
October 28, 20198/5/2019CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's DiseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseBiological: CT-P13 SC (Infliximab);Other: Placebo SCCelltrionNULLRecruiting18 Years75 YearsAll600Phase 3United States
7EUCTR2019-001087-30-PL
(EUCTR)
09/09/201924/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
8EUCTR2019-001087-30-GR
(EUCTR)
28/08/201926/07/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
9EUCTR2019-001087-30-ES
(EUCTR)
14/08/201910/09/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
10EUCTR2019-001087-30-FR
(EUCTR)
13/08/201914/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-001087-30-HU
(EUCTR)
09/08/201910/08/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
12EUCTR2019-001087-30-CZ
(EUCTR)
06/08/201906/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSINA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
13EUCTR2019-001087-30-LV
(EUCTR)
25/07/201904/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
14NCT02883452
(ClinicalTrials.gov)
September 29, 201625/8/2016A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative ColitisAn Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative ColitisCrohn's Disease;Ulcerative Colitis (Part 2 Only)Biological: CT-P13CelltrionNULLCompleted18 Years75 YearsAll181Phase 1Korea, Republic of
15NCT02539368
(ClinicalTrials.gov)
April 22, 201522/7/2015Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel DiseasePOST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's DiseaseDrug: CT-P13;Drug: RemicadePfizerHospira, now a wholly owned subsidiary of PfizerCompleted18 YearsN/AAll2565Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-004497-10-RO
(EUCTR)
31/10/201402/06/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
17NCT02096861
(ClinicalTrials.gov)
September 19, 201424/3/2014Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's DiseaseA Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's DiseaseCrohn's DiseaseBiological: CT-P13;Biological: RemicadeCelltrionPfizerCompleted18 Years75 YearsAll220Phase 3United States
18EUCTR2013-004497-10-GB
(EUCTR)
16/09/201423/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Celltrion, Inc.NULLNot Recruiting Female: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
19EUCTR2013-004497-10-DK
(EUCTR)
11/09/201402/06/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
20EUCTR2013-004497-10-NL
(EUCTR)
06/08/201403/06/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-004497-10-IT
(EUCTR)
01/08/201427/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
22EUCTR2013-004497-10-ES
(EUCTR)
25/07/201427/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn´s Disease Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
23EUCTR2013-004497-10-BE
(EUCTR)
16/07/201412/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
24EUCTR2013-004497-10-HU
(EUCTR)
02/07/201422/05/2014Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Celltrion, Inc.NULLNot RecruitingFemale: yes
Male: yes
214Phase 3United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of