97. Ulcerative colitis Clinical trials / Disease details


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202

  
19 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2019-004652-11-SI
(EUCTR)
28/08/202031/08/2020A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative ColitisRANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: RO5490261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany
2EUCTR2013-004278-88-PL
(EUCTR)
24/10/201709/09/2017A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
605Phase 3Korea, Republic of;Germany;Netherlands;Denmark;Australia;Romania;Brazil;Belgium;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;France;United Kingdom;Switzerland;Italy;Israel;Austria;Lithuania;Spain;Greece;United States
3EUCTR2013-004435-72-BG
(EUCTR)
16/03/201506/11/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMab Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2100Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
4EUCTR2013-004435-72-BE
(EUCTR)
22/12/201427/08/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2100Phase 3Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
5EUCTR2013-004278-88-BE
(EUCTR)
21/11/201410/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
605Phase 3Denmark;Netherlands;Germany;Korea, Republic of;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia
6EUCTR2013-004435-72-SK
(EUCTR)
13/11/201420/10/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2100Phase 3United States;Serbia;Portugal;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
7EUCTR2013-004435-72-DK
(EUCTR)
07/11/201421/07/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2100Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
8EUCTR2013-004435-72-HU
(EUCTR)
29/10/201430/10/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2625Phase 3Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
9EUCTR2013-004435-72-GB
(EUCTR)
24/10/201415/07/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2625Phase 3Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
10EUCTR2013-004278-88-DE
(EUCTR)
20/10/201406/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
605Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
11EUCTR2013-004435-72-NO
(EUCTR)
17/10/201406/08/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noLithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Vietnam;Switzerland;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Estonia;Hong Kong;Philippines;United States;Portugal;Serbia
12EUCTR2013-004435-72-CZ
(EUCTR)
02/10/201421/07/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studiesAN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noLithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Vietnam;Switzerland;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Estonia;Hong Kong;Philippines;United States;Portugal;Serbia
13EUCTR2013-004435-72-LT
(EUCTR)
30/09/201422/07/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
14EUCTR2013-004435-72-LV
(EUCTR)
05/09/201422/07/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2625 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
15EUCTR2013-004278-88-DK
(EUCTR)
21/08/201410/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Hungary;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Korea, Republic of
16EUCTR2013-004278-88-HU
(EUCTR)
04/08/201410/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
605Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
17EUCTR2013-004278-88-CZ
(EUCTR)
09/07/201409/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
605 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
18EUCTR2013-004278-88-AT
(EUCTR)
02/07/201411/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
605Phase 3United States;Greece;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of;Spain
19EUCTR2013-004278-88-LT
(EUCTR)
19/06/201424/04/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
605Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of