97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 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 | EUCTR2021-000630-34-GR (EUCTR) | 13/01/2023 | 11/11/2022 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 2 | EUCTR2021-000630-34-HR (EUCTR) | 27/12/2022 | 05/01/2023 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 3 | EUCTR2020-004300-34-IT (EUCTR) | 13/10/2021 | 30/08/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - NA | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 4 | EUCTR2020-004300-34-SK (EUCTR) | 18/09/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active 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] | Trade Name: ENTYVIO INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 5 | EUCTR2020-004300-34-HR (EUCTR) | 18/08/2021 | 02/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 6 | EUCTR2020-004300-34-HU (EUCTR) | 06/08/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 7 | EUCTR2020-004300-34-LT (EUCTR) | 25/06/2021 | 21/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 8 | EUCTR2020-004300-34-ES (EUCTR) | 02/06/2021 | 01/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 9 | EUCTR2020-004300-34-GR (EUCTR) | 01/06/2021 | 29/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 10 | EUCTR2017-002231-41-NL (EUCTR) | 14/05/2018 | 26/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary | ||
| 11 | EUCTR2017-002182-21-NL (EUCTR) | 20/03/2018 | 28/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom | ||
| 12 | EUCTR2017-002182-21-PL (EUCTR) | 17/01/2018 | 13/10/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 13 | EUCTR2017-002231-41-PL (EUCTR) | 17/01/2018 | 13/10/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 14 | EUCTR2017-002182-21-BE (EUCTR) | 10/01/2018 | 14/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 15 | EUCTR2017-002231-41-BE (EUCTR) | 10/01/2018 | 14/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 16 | EUCTR2017-002182-21-FR (EUCTR) | 18/12/2017 | 15/12/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 17 | EUCTR2017-002231-41-DE (EUCTR) | 18/12/2017 | 14/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 18 | EUCTR2017-002182-21-DE (EUCTR) | 18/12/2017 | 13/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 19 | EUCTR2017-002182-21-GB (EUCTR) | 16/11/2017 | 11/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 20 | EUCTR2017-002231-41-GB (EUCTR) | 15/11/2017 | 11/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 21 | EUCTR2017-002231-41-HU (EUCTR) | 25/10/2017 | 19/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 22 | EUCTR2017-002182-21-HU (EUCTR) | 25/10/2017 | 12/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 23 | EUCTR2015-000482-31-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 24 | EUCTR2015-000480-14-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 25 | EUCTR2015-000480-14-DE (EUCTR) | 14/06/2016 | 09/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 26 | EUCTR2015-000482-31-HR (EUCTR) | 13/06/2016 | 06/07/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 27 | EUCTR2015-000480-14-HR (EUCTR) | 10/06/2016 | 06/07/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 28 | EUCTR2015-000482-31-RO (EUCTR) | 02/06/2016 | 22/06/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 29 | EUCTR2015-000480-14-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 30 | EUCTR2015-000482-31-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 31 | EUCTR2015-000480-14-ES (EUCTR) | 29/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 32 | EUCTR2015-000482-31-ES (EUCTR) | 29/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn?s Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 33 | EUCTR2015-000482-31-NL (EUCTR) | 25/05/2016 | 27/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative Colitis Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: - Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 34 | EUCTR2015-000482-31-DE (EUCTR) | 09/05/2016 | 09/03/2016 | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 35 | EUCTR2015-000482-31-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 36 | EUCTR2015-000480-14-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 37 | EUCTR2015-000480-14-RO (EUCTR) | 05/05/2016 | 22/06/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 38 | EUCTR2015-000480-14-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 39 | EUCTR2015-000482-31-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 40 | EUCTR2015-000480-14-IT (EUCTR) | 18/04/2016 | 08/06/2021 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis. | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy. - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ENTYVIO - 300 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 41 | EUCTR2015-000482-31-IT (EUCTR) | 18/04/2016 | 22/01/2021 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn¿s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn¿s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 42 | JPRN-JapicCTI-163220 | 15/4/2016 | 08/04/2016 | A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease | Ulcerative colitis or Crohn's disease | Intervention name : Vedolizumab SC 108 mg INN of the intervention : Vedolizumab Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure, or Participants from current study who experience treatment failure while on study will receive vedolizumab SC 108 mg QW. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 18 | 80 | BOTH | 746 | Phase 3 | Japan, Refer to Othersection |
| 43 | EUCTR2015-000480-14-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 44 | EUCTR2015-000482-31-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 45 | EUCTR2015-000482-31-SE (EUCTR) | 05/04/2016 | 16/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 46 | EUCTR2015-000480-14-SE (EUCTR) | 04/04/2016 | 16/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 47 | EUCTR2015-000482-31-BG (EUCTR) | 23/03/2016 | 16/02/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 48 | EUCTR2015-000482-31-GB (EUCTR) | 21/03/2016 | 08/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 49 | EUCTR2015-000480-14-NL (EUCTR) | 21/03/2016 | 29/12/2015 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 50 | EUCTR2015-000480-14-BG (EUCTR) | 17/03/2016 | 16/02/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 51 | EUCTR2015-000480-14-GB (EUCTR) | 14/03/2016 | 07/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 52 | EUCTR2015-000939-33-HR (EUCTR) | 16/02/2016 | 28/04/2016 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 53 | EUCTR2015-000480-14-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 54 | EUCTR2015-000482-31-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 55 | EUCTR2015-000939-33-NL (EUCTR) | 21/01/2016 | 30/09/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 658 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 56 | EUCTR2015-000939-33-PT (EUCTR) | 08/01/2016 | 25/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 658 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 57 | EUCTR2015-000939-33-PL (EUCTR) | 08/01/2016 | 24/11/2015 | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Denmark;Australia;Latvia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 58 | EUCTR2015-000939-33-HU (EUCTR) | 05/01/2016 | 03/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 59 | EUCTR2015-000939-33-ES (EUCTR) | 05/01/2016 | 05/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 658 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 60 | EUCTR2015-000939-33-SK (EUCTR) | 11/12/2015 | 27/08/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 61 | EUCTR2015-000939-33-LT (EUCTR) | 08/12/2015 | 12/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 62 | EUCTR2015-000939-33-BE (EUCTR) | 07/12/2015 | 04/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 63 | EUCTR2015-000939-33-DK (EUCTR) | 04/12/2015 | 25/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 64 | EUCTR2015-000939-33-LV (EUCTR) | 27/11/2015 | 05/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 65 | EUCTR2015-000939-33-BG (EUCTR) | 26/11/2015 | 05/10/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 66 | EUCTR2015-000939-33-IT (EUCTR) | 24/11/2015 | 08/06/2021 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitiscompared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 SIRINGA PRERIEMPITA 0.8 ML + 1 TAMPONE IMBEVUTO DI ALCOL IN UN BLISTER | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Not Recruiting | Female: yes Male: yes | 658 | Phase 3 | Portugal;Serbia;United States;Taiwan;Hong Kong;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 67 | EUCTR2015-000939-33-EE (EUCTR) | 16/11/2015 | 10/11/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 68 | EUCTR2015-000939-33-CZ (EUCTR) | 11/11/2015 | 18/08/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 69 | EUCTR2015-000939-33-DE (EUCTR) | 10/11/2015 | 30/10/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 70 | EUCTR2015-000939-33-GB (EUCTR) | 06/11/2015 | 29/10/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Phase 3 | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 71 | EUCTR2014-005443-40-BE (EUCTR) | 02/06/2015 | 03/02/2015 | An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC | An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab | Academic Medical Center/ Gastroenterology | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Hungary;Belgium;Netherlands | ||
| 72 | NCT02039505 (ClinicalTrials.gov) | February 4, 2014 | 16/1/2014 | Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis | Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Vedolizumab;Drug: Vedolizumab placebo | Takeda | NULL | Completed | 15 Years | 80 Years | All | 292 | Phase 3 | Japan |
| 73 | JPRN-JapicCTI-142403 | 04/2/2014 | 27/12/2013 | Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis | Phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe ulcerative colitis | Ulcerative colitis | Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Induction Phase: Cohort 1/Cohort 2: Vedolizumab 300 mg; Vedolizumab 300 mg, IV intravenous (IV) infusion, once at Weeks 0, 2, and 6 in the induction phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Phase: Cohort 1, Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 0, 2 and 6 in the induction phase. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Maintenance Phase: Placebo continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | complete | 15 | 80 | BOTH | 292 | Phase 3 | Japan |
| 74 | EUCTR2008-002784-14-GB (EUCTR) | 26/03/2010 | 28/06/2010 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Serbia;Estonia;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 75 | EUCTR2008-002784-14-SE (EUCTR) | 12/02/2010 | 23/01/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 76 | EUCTR2008-002782-32-DK (EUCTR) | 18/12/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 77 | EUCTR2008-002784-14-DE (EUCTR) | 02/09/2009 | 02/06/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 17.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden;Greece;Spain;Ukraine;Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia | ||
| 78 | EUCTR2008-002782-32-DE (EUCTR) | 24/08/2009 | 23/04/2009 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe 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: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 995 | Phase 3 | Portugal;Serbia;Taiwan;Estonia;Hong Kong;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand | ||
| 79 | EUCTR2008-002784-14-AT (EUCTR) | 13/08/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 80 | EUCTR2008-002782-32-AT (EUCTR) | 13/08/2009 | 28/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB Other descriptive name: LDP-02 | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 81 | EUCTR2008-002784-14-IT (EUCTR) | 22/07/2009 | 17/03/2009 | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND | Patients with Ulcerative Colitis (UC) and Crohn?s Disease (CD) MedDRA version: 9.1;Level: LLT;Classification code 10045282 MedDRA version: 9.1;Level: PT;Classification code 10011401 | Product Name: Vedolizumab Product Code: MLN0002 | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 82 | EUCTR2008-002782-32-IT (EUCTR) | 22/07/2009 | 22/01/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - ND | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - ND | Patients with Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 83 | EUCTR2008-002782-32-GB (EUCTR) | 20/07/2009 | 27/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 84 | EUCTR2008-002782-32-CZ (EUCTR) | 13/07/2009 | 31/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 85 | NCT00790933 (ClinicalTrials.gov) | May 22, 2009 | 5/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Completed | 18 Years | N/A | All | 2243 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic |
| 86 | EUCTR2008-002784-14-EE (EUCTR) | 28/04/2009 | 27/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia | ||
| 87 | EUCTR2008-002784-14-BE (EUCTR) | 21/04/2009 | 14/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 88 | EUCTR2008-002784-14-HU (EUCTR) | 20/04/2009 | 27/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 89 | EUCTR2008-002782-32-HU (EUCTR) | 14/04/2009 | 27/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 90 | EUCTR2008-002782-32-GR (EUCTR) | 07/04/2009 | 05/11/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 91 | EUCTR2008-002784-14-GR (EUCTR) | 07/04/2009 | 05/11/2009 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 92 | EUCTR2008-002784-14-ES (EUCTR) | 02/04/2009 | 18/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) | Ulcerative Colitis and Crohn?s DiseaseColitis ulcerosa (CU) y enfermedad de Crohn (EC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 93 | EUCTR2008-002784-14-FR (EUCTR) | 23/03/2009 | 14/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 94 | EUCTR2008-002782-32-FR (EUCTR) | 13/03/2009 | 14/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 95 | EUCTR2008-002782-32-PT (EUCTR) | 09/03/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 96 | EUCTR2008-002784-14-PT (EUCTR) | 06/03/2009 | 06/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 97 | EUCTR2008-002782-32-ES (EUCTR) | 02/03/2009 | 23/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave | Moderate to Severe Ulcerative ColitisColitis ulcerosa moderada o grave MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 98 | EUCTR2008-002784-14-CZ (EUCTR) | 20/02/2009 | 31/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 99 | EUCTR2008-002784-14-NL (EUCTR) | 18/02/2009 | 05/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 100 | EUCTR2008-002782-32-NL (EUCTR) | 18/02/2009 | 05/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland | ||
| 101 | EUCTR2008-002782-32-BE (EUCTR) | 08/02/2009 | 14/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 102 | EUCTR2008-002783-33-AT (EUCTR) | 29/01/2009 | 28/10/2008 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Crohn's Disease MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden | ||
| 103 | EUCTR2008-002784-14-MT (EUCTR) | 28/01/2009 | 25/11/2008 | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece | ||
| 104 | EUCTR2008-002782-32-MT (EUCTR) | 28/01/2009 | 02/02/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Iceland;Malta;Denmark;Belgium;Estonia;Spain;Greece | ||
| 105 | EUCTR2008-002783-33-MT (EUCTR) | 28/01/2009 | 25/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece | ||
| 106 | EUCTR2008-002784-14-IS (EUCTR) | 27/01/2009 | 06/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients WithUlcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden | ||
| 107 | EUCTR2008-002784-14-BG (EUCTR) | 16/01/2009 | 12/01/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 108 | EUCTR2008-002784-14-SK (EUCTR) | 15/01/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 109 | EUCTR2008-002782-32-EE (EUCTR) | 09/01/2009 | 24/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 110 | EUCTR2008-002784-14-IE (EUCTR) | 09/01/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden | ||
| 111 | EUCTR2008-002782-32-IS (EUCTR) | 09/01/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands | ||
| 112 | EUCTR2008-002782-32-IE (EUCTR) | 09/01/2009 | 28/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 113 | EUCTR2008-002782-32-BG (EUCTR) | 08/01/2009 | 12/01/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 114 | NCT00783718 (ClinicalTrials.gov) | January 2009 | 31/10/2008 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: vedolizumab;Other: Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 895 | Phase 3 | United States;Canada;Puerto Rico |
| 115 | EUCTR2008-002784-14-LV (EUCTR) | 19/12/2008 | 31/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 116 | EUCTR2008-002782-32-LV (EUCTR) | 19/12/2008 | 31/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | ||
| 117 | NCT00619489 (ClinicalTrials.gov) | December 2007 | 11/2/2008 | Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: vedolizumab | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 72 | Phase 2 | Canada |
| 118 | NCT01177228 (ClinicalTrials.gov) | May 2007 | 5/8/2010 | Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis | A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Vedolizumab;Drug: Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 47 | Phase 2 | NULL |
| 119 | EUCTR2017-002231-41-FR (EUCTR) | 15/12/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | |||
| 120 | EUCTR2020-004300-34-BE (EUCTR) | 26/01/2022 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 121 | EUCTR2021-000630-34-CZ (EUCTR) | 27/10/2022 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 122 | EUCTR2021-000630-34-PL (EUCTR) | 05/10/2022 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 123 | EUCTR2020-004300-34-CZ (EUCTR) | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan |