97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,527 薬物数 : 1,468 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

  
78 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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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
2EUCTR2013-004279-11-FR
(EUCTR)
03/06/201909/04/2019A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
3EUCTR2013-004277-27-HU
(EUCTR)
11/04/201925/02/2019A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
4EUCTR2013-004277-27-CZ
(EUCTR)
18/03/201929/03/2019A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand
5EUCTR2017-003649-10-GB
(EUCTR)
15/05/201811/12/2017A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1Spain;Poland;Belgium;Germany;United Kingdom
6EUCTR2017-003649-10-BE
(EUCTR)
02/05/201827/02/2018A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1Spain;Poland;Belgium;Germany;United Kingdom
7EUCTR2017-003649-10-DE
(EUCTR)
30/04/201807/02/2018A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
60Phase 1United States;Poland;Belgium;Spain;Germany;United Kingdom
8NCT03478956
(ClinicalTrials.gov)
March 27, 201826/3/2018A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's DiseaseA Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: EtrolizumabHoffmann-La RocheNULLActive, not recruiting4 Years17 YearsAll24Phase 1Belgium;Poland;Spain;United Kingdom;Germany;United States
9EUCTR2013-004278-88-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
10EUCTR2013-004280-31-SK
(EUCTR)
21/10/201626/07/2016A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL 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: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany
11EUCTR2013-004280-31-PL
(EUCTR)
29/09/201612/09/2016 A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL 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: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany;South Africa;Denmark;Brazil;Poland;Canada;Mexico;Hungary;Czech Republic;Italy;Israel;Ukraine;Slovakia;United States
12EUCTR2013-004435-72-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
13EUCTR2013-004435-72-IT
(EUCTR)
27/02/201529/09/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES - Cottonwood Ulcerative colitis
MedDRA version: 17.0;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: ND
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2568Phase 3Serbia;Portugal;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;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
14EUCTR2013-004435-72-DE
(EUCTR)
06/02/201518/07/2014An 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: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2100Phase 3Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;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
15EUCTR2013-004435-72-NL
(EUCTR)
28/01/201504/08/2014An 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: unknown
Other descriptive name: ETROLIZUMAB
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;Latvia;Netherlands;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
16EUCTR2013-004282-14-NL
(EUCTR)
13/01/201504/08/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Netherlands;Germany;Norway;Sweden;Korea, Republic of
17EUCTR2013-004279-11-BG
(EUCTR)
12/01/201506/10/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
18EUCTR2013-004277-27-BG
(EUCTR)
12/01/201506/10/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
19EUCTR2013-004282-14-PT
(EUCTR)
09/01/201523/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
20EUCTR2013-004435-72-PT
(EUCTR)
09/01/201523/07/2014An 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: ETROLIZUMAB
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;United States;Portugal;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
21NCT02136069
(ClinicalTrials.gov)
December 24, 201415/4/2014A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF InhibitorsUlcerative ColitisDrug: Etrolizumab;Drug: Infliximab;Other: Placebo (IV);Other: Placebo (Injection)Hoffmann-La RocheNULLCompleted18 Years80 YearsAll397Phase 3Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Portugal;Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Philippines;Vietnam
22EUCTR2013-004435-72-ES
(EUCTR)
22/12/201411/08/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES Ulcerative colitis
MedDRA version: 17.0;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: -
Other descriptive name: ETROLIZUMAB
Roche Farma S.A. en nombre de F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2568Phase 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
23EUCTR2013-004435-72-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
24EUCTR2013-004280-31-DK
(EUCTR)
17/12/201429/07/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - Laurel 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
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Denmark;South Africa;Israel;Germany
25EUCTR2013-004282-14-BE
(EUCTR)
11/12/201427/08/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
26EUCTR2013-004277-27-GR
(EUCTR)
08/12/201408/12/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II Ulcerative Colitis
MedDRA version: 17.1;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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;New Zealand
27EUCTR2013-004435-72-FR
(EUCTR)
02/12/201422/06/2015An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES Ulcerative colitis
MedDRA version: 18.0;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
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2568Phase 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
28EUCTR2013-004282-14-ES
(EUCTR)
25/11/201406/08/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 17.0;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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Roche Farma S.A. en nombre de F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
29EUCTR2013-004280-31-DE
(EUCTR)
24/11/201430/07/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL 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: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany
30EUCTR2013-004278-88-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
31EUCTR2013-004278-88-NL
(EUCTR)
19/11/201423/06/2014A 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 Beta 7, 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;Australia;Denmark;Netherlands;Germany;Korea, Republic of
32NCT02171429
(ClinicalTrials.gov)
November 14, 201420/6/2014A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF InhibitorsUlcerative ColitisDrug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab PlaceboHoffmann-La RocheNULLCompleted18 Years80 YearsAll358Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Czechia;France;Greece;Hungary;Latvia;Lithuania;Malaysia;New Zealand;Poland;Russian Federation;Turkey;Ukraine
33EUCTR2013-004435-72-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
34EUCTR2013-004279-11-SK
(EUCTR)
13/11/201408/10/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
35EUCTR2013-004282-14-IT
(EUCTR)
10/11/201416/09/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 17.0;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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
36EUCTR2013-004282-14-DE
(EUCTR)
10/11/201418/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
37EUCTR2013-004435-72-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
38EUCTR2013-004435-72-SE
(EUCTR)
05/11/201416/07/2014An 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: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2625Phase 3Bulgaria;Norway;Germany;New Zealand;Sweden;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Serbia;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
39NCT02163759
(ClinicalTrials.gov)
November 4, 201412/6/2014A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF InhibitorsUlcerative ColitisDrug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab PlaceboHoffmann-La RocheNULLCompleted18 Years80 YearsAll358Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Estonia;France;Hong Kong;Mexico;Poland;Russian Federation;Serbia;Slovakia;Ukraine
40EUCTR2013-004282-14-HU
(EUCTR)
29/10/201430/10/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
41EUCTR2013-004435-72-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
42EUCTR2013-004435-72-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
43EUCTR2013-004278-88-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
44EUCTR2013-004435-72-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
45EUCTR2013-004282-14-NO
(EUCTR)
17/10/201404/08/2014A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 17.0;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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Singapore;Romania;South Africa;Norway;Germany;Netherlands;Sweden;Korea, Republic of;Canada;Belgium;Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary
46EUCTR2013-004280-31-CZ
(EUCTR)
07/10/201421/07/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL 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: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany
47EUCTR2013-004279-11-EE
(EUCTR)
03/10/201409/09/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I Ulcerative Colitis
MedDRA version: 18.0;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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
48EUCTR2013-004435-72-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
49EUCTR2013-004435-72-GR
(EUCTR)
30/09/201420/08/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES Ulcerative colitis
MedDRA version: 17.0;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
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2568Phase 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
50EUCTR2013-004277-27-LT
(EUCTR)
30/09/201422/07/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
51EUCTR2013-004435-72-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
52EUCTR2013-004282-14-GB
(EUCTR)
29/09/201415/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
53EUCTR2013-004278-88-GR
(EUCTR)
22/09/201403/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant 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 ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS Ulcerative colitis
MedDRA version: 17.0;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
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
54EUCTR2013-004435-72-EE
(EUCTR)
19/09/201429/07/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase 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
Other descriptive name: ETROLIZUMAB
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
55EUCTR2013-004280-31-HU
(EUCTR)
19/09/201431/07/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL 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: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Ukraine;Israel;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany
56EUCTR2013-004282-14-CZ
(EUCTR)
16/09/201418/07/2014A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania
57NCT02118584
(ClinicalTrials.gov)
September 15, 201416/4/2014Study for Participants 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 StudiesUlcerative ColitisDrug: EtrolizumabHoffmann-La RocheNULLActive, not recruiting18 YearsN/AAll1822Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic;Philippines;Sweden;Vietnam
58EUCTR2013-004435-72-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
59EUCTR2013-004278-88-FR
(EUCTR)
04/09/201422/06/2015A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant 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 ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS Ulcerative colitis
MedDRA version: 18.0;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
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
60EUCTR2013-004435-72-AT
(EUCTR)
03/09/201422/07/2014An 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
Other descriptive name: ETROLIZUMAB
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;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
61EUCTR2013-004282-14-AT
(EUCTR)
03/09/201422/07/2014A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA 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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
62EUCTR2013-004278-88-IT
(EUCTR)
01/09/201401/07/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant 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 ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS Ulcerative colitis
MedDRA version: 17.0;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
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
63EUCTR2013-004278-88-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
64EUCTR2013-004435-72-HR
(EUCTR)
12/08/201405/09/2014An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studiesAN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES 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: ETROLIZUMAB
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
65EUCTR2013-004277-27-HR
(EUCTR)
12/08/201405/09/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
66NCT02165215
(ClinicalTrials.gov)
August 12, 201413/6/2014A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) InhibitorsPhase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF InhibitorsColitis, UlcerativeDrug: Etrolizumab;Drug: PlaceboHoffmann-La RocheNULLCompleted18 Years80 YearsAll359Phase 3United States;Brazil;Canada;Czechia;Denmark;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Slovakia;South Africa;Ukraine;Czech Republic
67EUCTR2013-004278-88-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
68EUCTR2013-004282-14-FR
(EUCTR)
28/07/201422/06/2015A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS Ulcerative Colitis
MedDRA version: 18.0;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: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
720Phase 3Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
69EUCTR2013-004277-27-LV
(EUCTR)
28/07/201421/07/2014A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitorsPHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II 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: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;New Zealand;Latvia;Bulgaria;Australia;Croatia;Malaysia
70EUCTR2013-004278-88-ES
(EUCTR)
25/07/201413/06/2014A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant 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 ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS Ulcerative colitis
MedDRA version: 17.0;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: -
Other descriptive name: ETROLIZUMAB
Roche Farma S.A en nombre de F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
71EUCTR2013-004278-88-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
72EUCTR2013-004278-88-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
73EUCTR2013-004278-88-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
74NCT02100696
(ClinicalTrials.gov)
May 21, 201427/3/2014A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) InhibitorsPhase 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 InhibitorsUlcerative ColitisDrug: Etrozulimab;Drug: PlaceboHoffmann-La RocheNULLCompleted18 Years80 YearsAll609Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Spain;Switzerland;United Kingdom;Czech Republic;New Zealand
75EUCTR2011-003409-36-CZ
(EUCTR)
11/01/201218/11/2011A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: RO5490261/F02
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;New Zealand;United Kingdom
76EUCTR2011-003409-36-GB
(EUCTR)
02/12/201106/12/2011A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis Ulcerative colitis
MedDRA version: 18.0;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 / F02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;New Zealand;United Kingdom
77NCT01461317
(ClinicalTrials.gov)
November 29, 201112/10/2011Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative ColitisA Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: EtrolizumabGenentech, Inc.NULLCompleted18 Years75 YearsAll121Phase 2United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom;Czech Republic
78EUCTR2017-003649-10-PL
(EUCTR)
11/12/2017A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s DiseaseA PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: 549-0261/F02-01
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: ETROLIZUMAB
F. Hoffmann-La Roche LtdNULLNA Female: yes
Male: yes
60 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom;Germany;Poland;Spain;Belgium;United States