96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | EUCTR2015-000481-58-NL (EUCTR) | 14/07/2016 | 15/02/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - 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 | 824 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 2 | 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 | Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Czechia;Bosnia and Herzegovina;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;United States;Serbia | ||
| 3 | EUCTR2015-000481-58-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - 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 | 824 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 4 | EUCTR2015-000481-58-DE (EUCTR) | 14/06/2016 | 09/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - 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 | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 5 | 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 | ||
| 6 | EUCTR2015-000481-58-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - 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 | 824 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 7 | 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 | ||
| 8 | EUCTR2015-000481-58-ES (EUCTR) | 29/05/2016 | 20/04/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn?s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn?s Disease | Crohn s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;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 | 824 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | EUCTR2015-000481-58-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease;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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 824 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 12 | 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 | Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Czechia;Korea, Republic of;Bosnia and Herzegovina;Netherlands;South Africa;Denmark;Australia;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;Serbia;United States | ||
| 13 | 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 | ||
| 14 | EUCTR2015-000481-58-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - 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 | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 15 | 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 | ||
| 16 | EUCTR2015-000481-58-IT (EUCTR) | 18/04/2016 | 11/02/2021 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn's Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as MaintenanceTherapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio 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 | 824 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;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;Bulgaria;Germany;Japan;Sweden | ||
| 17 | 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 | ||
| 18 | EUCTR2015-000481-58-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - 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 | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 19 | 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 | ||
| 20 | EUCTR2015-000481-58-SE (EUCTR) | 05/04/2016 | 17/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;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 | 824 | 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;Italy;Australia;Denmark;South Africa;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 | ||
| 21 | 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 | ||
| 22 | EUCTR2015-000481-58-BG (EUCTR) | 31/03/2016 | 16/02/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - 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 | 824 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 23 | 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 | 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 | EUCTR2015-000482-31-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 | ||
| 25 | EUCTR2015-000481-58-GB (EUCTR) | 14/03/2016 | 08/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’ | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Entyvio 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 | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 26 | 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 | ||
| 27 | EUCTR2015-000481-58-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Turkey;Lithuania;Korea, Republic of;Bosnia and Herzegovina;Netherlands;South Africa;Denmark;Australia;Italy;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;Taiwan;United States;Serbia |