Vatelizumab (DrugBank: Vatelizumab)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 6 |
| 97 | 潰瘍性大腸炎 | 10 |
| 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 | EUCTR2014-001643-20-SE (EUCTR) | 03/07/2015 | 19/01/2015 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Germany;Italy;Switzerland;Sweden;United States;Czech Republic;Mexico;Canada;Poland;Russian Federation | ||
| 2 | EUCTR2014-003265-19-PL (EUCTR) | 12/05/2015 | 26/02/2015 | Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839 | A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839 | Relapsing-remitting multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 3 | EUCTR2014-001643-20-DE (EUCTR) | 10/02/2015 | 18/08/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 4 | NCT02306811 (ClinicalTrials.gov) | February 2015 | 1/12/2014 | Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839 | A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839 | Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 62 | Phase 2 | United States;Canada;Poland;Russian Federation |
| 5 | EUCTR2014-001643-20-PL (EUCTR) | 23/01/2015 | 31/10/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 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 |
| 6 | NCT02222948 (ClinicalTrials.gov) | September 2014 | 20/8/2014 | Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab;Drug: Placebo (for Vatelizumab) | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | 55 Years | Both | 112 | Phase 2 | United States;Canada;Poland;Russian Federation;Sweden |
| 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 | EUCTR2013-001012-30-DE (EUCTR) | 20/01/2014 | 07/10/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Belgium;Austria;Germany;Italy | |||
| 2 | EUCTR2013-001012-30-PL (EUCTR) | 17/10/2013 | 05/09/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Austria;Germany;Italy | |||
| 3 | EUCTR2013-001012-30-BE (EUCTR) | 09/10/2013 | 12/08/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Canada;Poland;Belgium;Austria;Germany;Italy | ||
| 4 | EUCTR2013-001012-30-IT (EUCTR) | 30/09/2013 | 02/07/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Austria;Germany;Italy | |||
| 5 | EUCTR2012-002013-19-DE (EUCTR) | 25/09/2013 | 17/05/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | France;United States;Canada;Belgium;Poland;Austria;Germany;Italy | |||
| 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 |
| 6 | EUCTR2012-002013-19-PL (EUCTR) | 12/09/2013 | 14/06/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | France;United States;Canada;Belgium;Poland;Austria;Germany;Italy | |||
| 7 | EUCTR2013-001012-30-AT (EUCTR) | 04/09/2013 | 12/07/2013 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 80 | United States;Canada;Poland;Austria;Germany;Italy | |||
| 8 | EUCTR2012-002013-19-BE (EUCTR) | 19/07/2013 | 19/02/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 2 | France;United States;Canada;Poland;Belgium;Austria;Germany;Italy | ||
| 9 | EUCTR2012-002013-19-IT (EUCTR) | 02/06/2013 | 08/04/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | United States;France;Canada;Poland;Belgium;Austria;Germany;Italy | |||
| 10 | EUCTR2012-002013-19-AT (EUCTR) | 16/04/2013 | 21/03/2013 | Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis | A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab | Sanofi aventis Recherche&Développement | NULL | Not Recruiting | Female: yes Male: yes | 93 | France;United States;Canada;Belgium;Poland;Austria;Germany;Italy |