97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004652-11-SI (EUCTR) | 28/08/2020 | 31/08/2020 | A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis | RANDOMIZED, 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;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 | ||
| 2 | EUCTR2013-004278-88-PL (EUCTR) | 24/10/2017 | 09/09/2017 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 605 | Phase 3 | Korea, 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 | ||
| 3 | EUCTR2013-004435-72-BG (EUCTR) | 16/03/2015 | 06/11/2014 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | Portugal;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 | ||
| 4 | EUCTR2013-004435-72-BE (EUCTR) | 22/12/2014 | 27/08/2014 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | 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;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 5 | EUCTR2013-004278-88-BE (EUCTR) | 21/11/2014 | 10/06/2014 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | Denmark;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 | ||
| 6 | EUCTR2013-004278-88-NL (EUCTR) | 19/11/2014 | 23/06/2014 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United 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 | ||
| 7 | EUCTR2013-004435-72-SK (EUCTR) | 13/11/2014 | 20/10/2014 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | United 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 | ||
| 8 | EUCTR2013-004435-72-DK (EUCTR) | 07/11/2014 | 21/07/2014 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2100 | Phase 3 | Portugal;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 | ||
| 9 | EUCTR2013-004435-72-HU (EUCTR) | 29/10/2014 | 30/10/2014 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2625 | Phase 3 | 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;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 10 | EUCTR2013-004435-72-GB (EUCTR) | 24/10/2014 | 15/07/2014 | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2625 | Phase 3 | 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;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 11 | EUCTR2013-004278-88-DE (EUCTR) | 20/10/2014 | 06/06/2014 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United 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 | ||
| 12 | EUCTR2013-004435-72-NO (EUCTR) | 17/10/2014 | 06/08/2014 | An 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 Ltd | NULL | Authorised-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): no | Lithuania;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 | ||
| 13 | EUCTR2013-004435-72-CZ (EUCTR) | 02/10/2014 | 21/07/2014 | An 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 Ltd | NULL | Authorised-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): no | Lithuania;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 | ||
| 14 | EUCTR2013-004435-72-LT (EUCTR) | 30/09/2014 | 22/07/2014 | An 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 Ltd | NULL | Authorised-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): no | 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;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 15 | EUCTR2013-004435-72-LV (EUCTR) | 05/09/2014 | 22/07/2014 | An 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 Ltd | NULL | Authorised-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): no | 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;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 16 | EUCTR2013-004278-88-DK (EUCTR) | 21/08/2014 | 10/06/2014 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Hungary;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 | ||
| 17 | EUCTR2013-004278-88-HU (EUCTR) | 04/08/2014 | 10/06/2014 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 605 | Phase 3 | United 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 | ||
| 18 | EUCTR2013-004278-88-CZ (EUCTR) | 09/07/2014 | 09/06/2014 | A 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 Ltd | NULL | Not 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): no | United 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 | ||
| 19 | EUCTR2013-004278-88-AT (EUCTR) | 02/07/2014 | 11/06/2014 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United 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 | ||
| 20 | EUCTR2013-004278-88-LT (EUCTR) | 19/06/2014 | 24/04/2014 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United 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 | ||
| 21 | EUCTR2011-003409-36-DE (EUCTR) | 09/02/2012 | 17/11/2011 | A study to evaluate the long term safety of rhuMab Beta7 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 rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 22 | EUCTR2011-003409-36-CZ (EUCTR) | 11/01/2012 | 18/11/2011 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;New Zealand;United Kingdom | ||
| 23 | EUCTR2011-003409-36-ES (EUCTR) | 23/12/2011 | 18/11/2011 | A study to evaluate the long term safety of rhuMab Beta7 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 rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 24 | EUCTR2011-003409-36-GB (EUCTR) | 02/12/2011 | 06/12/2011 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;New Zealand;United Kingdom | ||
| 25 | EUCTR2011-003409-36-BE (EUCTR) | 14/11/2011 | 14/11/2011 | A study to evaluate the long term safety of rhuMab Beta7 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 rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 26 | EUCTR2011-000897-80-DE (EUCTR) | 19/10/2011 | 15/07/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Israel;Germany;United States;Hungary;Czech Republic;Canada;Spain;Australia;United Kingdom;New Zealand | ||
| 27 | EUCTR2011-000897-80-ES (EUCTR) | 23/09/2011 | 04/07/2011 | A clinical study to investigate the safety and efficacy of the productrhuMAb BETA7 in treating patients with ulcerative colitis, a form ofinflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDYTO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 INPATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 28 | EUCTR2011-000897-80-CZ (EUCTR) | 14/09/2011 | 29/06/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 29 | EUCTR2011-000897-80-GB (EUCTR) | 06/09/2011 | 29/06/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;New Zealand;United Kingdom | ||
| 30 | EUCTR2011-000897-80-HU (EUCTR) | 05/09/2011 | 07/09/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 31 | NCT01336465 (ClinicalTrials.gov) | September 2011 | 14/4/2011 | Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis | Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: placebo;Drug: rhuMAb Beta7 | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | Both | 124 | Phase 2 | United States;Australia;Belgium;Canada;Czech Republic;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom |
| 32 | EUCTR2011-000897-80-BE (EUCTR) | 16/08/2011 | 27/06/2011 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7 | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand | ||
| 33 | NCT00694980 (ClinicalTrials.gov) | September 2008 | 7/6/2008 | A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis | A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: placebo;Drug: rhuMAb Beta7 | Genentech, Inc. | NULL | Completed | 18 Years | 70 Years | Both | 48 | Phase 1 | United States;Belgium;Canada;Germany;Netherlands;United Kingdom |