GED-0301 ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 96 | クローン病 | 63 |
| 97 | 潰瘍性大腸炎 | 4 |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | NCT02974322 (ClinicalTrials.gov) | December 1, 2017 | 23/11/2016 | A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | NULL | Withdrawn | 12 Years | N/A | All | 0 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic |
| 2 | EUCTR2015-001924-40-HR (EUCTR) | 13/10/2017 | 02/11/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 3 | EUCTR2015-001924-40-PT (EUCTR) | 26/06/2017 | 01/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 4 | EUCTR2015-001924-40-BE (EUCTR) | 14/06/2017 | 06/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden;Netherlands;Latvia;Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark | ||
| 5 | EUCTR2015-001924-40-IT (EUCTR) | 12/06/2017 | 23/02/2018 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Other descriptive name: GED-0301 Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Other descriptive name: GED-0301 | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 6 | EUCTR2015-001924-40-GB (EUCTR) | 17/05/2017 | 27/01/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | 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;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 7 | EUCTR2015-001924-40-GR (EUCTR) | 05/05/2017 | 20/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | 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;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 8 | EUCTR2015-001924-40-NL (EUCTR) | 24/04/2017 | 08/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 9 | EUCTR2015-001924-40-FR (EUCTR) | 20/04/2017 | 27/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | 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;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 10 | EUCTR2015-001924-40-DE (EUCTR) | 12/04/2017 | 06/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | 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;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 11 | EUCTR2015-001924-40-ES (EUCTR) | 07/04/2017 | 10/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 12 | EUCTR2015-001924-40-HU (EUCTR) | 07/04/2017 | 09/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden | ||
| 13 | EUCTR2015-001924-40-DK (EUCTR) | 04/04/2017 | 07/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | 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;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 14 | EUCTR2015-001924-40-LV (EUCTR) | 31/03/2017 | 02/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 15 | EUCTR2015-001963-37-FI (EUCTR) | 30/03/2017 | 23/02/2017 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 16 | EUCTR2015-001924-40-FI (EUCTR) | 30/03/2017 | 28/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 17 | EUCTR2015-001924-40-CZ (EUCTR) | 21/03/2017 | 01/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden | ||
| 18 | EUCTR2015-001924-40-SK (EUCTR) | 16/03/2017 | 03/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | 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;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden | ||
| 19 | EUCTR2015-001924-40-AT (EUCTR) | 21/02/2017 | 18/01/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 20 | EUCTR2015-001925-18-FI (EUCTR) | 25/01/2017 | 22/12/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 21 | EUCTR2015-001963-37-GR (EUCTR) | 28/09/2016 | 01/06/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 22 | NCT02641392 (ClinicalTrials.gov) | July 25, 2016 | 23/12/2015 | A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease | A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease | Crohn's Disease | Drug: GED-0301;Other: Placebo | Celgene | NULL | Terminated | 12 Years | N/A | All | 310 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Estonia;Finland;Malaysia;New Zealand;South Africa |
| 23 | EUCTR2015-001963-37-BG (EUCTR) | 23/06/2016 | 13/04/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 24 | EUCTR2015-001925-18-GR (EUCTR) | 01/06/2016 | 06/04/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | France;Australia;Denmark;Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 25 | EUCTR2015-001925-18-HR (EUCTR) | 09/05/2016 | 06/07/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 26 | EUCTR2015-001963-37-HR (EUCTR) | 05/05/2016 | 21/06/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 27 | EUCTR2015-001963-37-BE (EUCTR) | 03/05/2016 | 10/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 28 | EUCTR2015-001925-18-BG (EUCTR) | 20/04/2016 | 18/03/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 29 | EUCTR2015-001963-37-DK (EUCTR) | 15/04/2016 | 22/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Sweden;Norway;Germany;New Zealand;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria | ||
| 30 | EUCTR2015-001963-37-SK (EUCTR) | 14/04/2016 | 07/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 31 | EUCTR2015-001925-18-SK (EUCTR) | 14/04/2016 | 30/11/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 32 | EUCTR2015-001963-37-ES (EUCTR) | 08/04/2016 | 03/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn?s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn?s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 33 | NCT02685683 (ClinicalTrials.gov) | April 4, 2016 | 15/2/2016 | Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease | A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: GED-0301 | Celgene | NULL | Terminated | 18 Years | N/A | All | 18 | Phase 2 | Italy |
| 34 | EUCTR2015-001925-18-CZ (EUCTR) | 01/04/2016 | 22/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 35 | EUCTR2015-001963-37-CZ (EUCTR) | 01/04/2016 | 22/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn's disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 36 | EUCTR2015-001963-37-PT (EUCTR) | 28/03/2016 | 10/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 37 | EUCTR2015-001925-18-PT (EUCTR) | 28/03/2016 | 10/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 38 | EUCTR2015-001925-18-BE (EUCTR) | 25/03/2016 | 20/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Serbia;Portugal;United States;Estonia | ||
| 39 | EUCTR2015-001963-37-IT (EUCTR) | 23/03/2016 | 23/02/2018 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 40 | EUCTR2015-001963-37-GB (EUCTR) | 15/03/2016 | 29/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;United States;Serbia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Pakistan;Finland;Oman;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 41 | EUCTR2015-001925-18-ES (EUCTR) | 07/03/2016 | 04/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn?s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 42 | EUCTR2015-001925-18-DK (EUCTR) | 04/03/2016 | 06/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 43 | EUCTR2015-001963-37-DE (EUCTR) | 26/02/2016 | 11/01/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 44 | EUCTR2015-001925-18-GB (EUCTR) | 24/02/2016 | 18/11/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety o | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 45 | EUCTR2015-001925-18-LV (EUCTR) | 18/02/2016 | 01/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 46 | EUCTR2015-001963-37-LV (EUCTR) | 18/02/2016 | 01/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 47 | EUCTR2015-001963-37-HU (EUCTR) | 15/02/2016 | 17/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 48 | EUCTR2015-001925-18-HU (EUCTR) | 15/02/2016 | 17/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 49 | EUCTR2015-001963-37-SE (EUCTR) | 10/02/2016 | 17/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 50 | EUCTR2015-001925-18-DE (EUCTR) | 09/02/2016 | 07/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 51 | EUCTR2015-001693-18-IT (EUCTR) | 29/01/2016 | 07/03/2018 | - | A Phase 2, Open-Label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects with Active Crohn's Disease - GED-0301-CD-005 | Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | ||
| 52 | EUCTR2015-001963-37-AT (EUCTR) | 29/01/2016 | 22/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 53 | EUCTR2015-001925-18-AT (EUCTR) | 29/01/2016 | 22/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 54 | EUCTR2015-001925-18-SE (EUCTR) | 27/01/2016 | 25/11/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 55 | EUCTR2015-001963-37-EE (EUCTR) | 29/12/2015 | 07/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 56 | EUCTR2015-001925-18-EE (EUCTR) | 29/12/2015 | 07/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 57 | NCT02596893 (ClinicalTrials.gov) | December 8, 2015 | 3/11/2015 | Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | NULL | Terminated | 18 Years | N/A | All | 701 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Former Serbia and Montenegro;South Africa |
| 58 | NCT02367183 (ClinicalTrials.gov) | April 8, 2015 | 13/2/2015 | A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease | A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease. | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | NULL | Completed | 18 Years | N/A | All | 64 | Phase 1 | United States;Australia;Canada;Hungary;Slovakia |
| 59 | EUCTR2011-002640-27-DE (EUCTR) | 08/03/2013 | 23/08/2012 | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis) | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY | ACTIVE CROHN'S DISEASE MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: 40 mg INN or Proposed INN: NA Other descriptive name: GED-0301 Product Name: GED-0301 Product Code: 10 mg INN or Proposed INN: NA Other descriptive name: GED-0301 | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Germany;Italy | ||
| 60 | EUCTR2011-005678-47-IT (EUCTR) | 19/01/2012 | 21/12/2011 | A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. | A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. - IGON 2 | CROHN'S DISEASE IN REMISSION PHASE MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: NA | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | |||
| 61 | EUCTR2011-002640-27-IT (EUCTR) | 14/07/2011 | 09/02/2012 | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis) | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY | ACTIVE CROHN'S DISEASE MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: NA INN or Proposed INN: NA Other descriptive name: NA | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany;Italy | |||
| 62 | EUCTR2015-001924-40-PL (EUCTR) | 29/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | |||
| 63 | EUCTR2015-001925-18-NO (EUCTR) | 27/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden |
97. 潰瘍性大腸炎
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 | EUCTR2015-003364-36-HU (EUCTR) | 09/02/2016 | 02/12/2015 | A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis. | A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. | Ulcerative Colitis. MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Bulgaria | ||
| 2 | EUCTR2015-003364-36-BG (EUCTR) | 09/02/2016 | 28/01/2016 | A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis. | A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. | Ulcerative Colitis. MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Bulgaria | ||
| 3 | EUCTR2015-003364-36-SK (EUCTR) | 22/01/2016 | 07/12/2015 | A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis. | A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. | Ulcerative Colitis. MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Bulgaria | ||
| 4 | NCT02601300 (ClinicalTrials.gov) | December 14, 2015 | 6/11/2015 | An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis | A Phase 2, Open-Label, Multicenter Study to Explore the Efficacy and Safety of MONGERSON (GED-0301) in Subjects With Active Ulcerative Colitis. | Colitis, Ulcerative | Drug: GED-0301 | Celgene | NULL | Completed | 18 Years | N/A | All | 41 | Phase 2 | United States;Bulgaria;Canada;Hungary;Poland;Slovakia |