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

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001643-20-SE
(EUCTR)
03/07/201519/01/2015Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple SclerosisA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
168Phase 2Germany;Italy;Switzerland;Sweden;United States;Czech Republic;Mexico;Canada;Poland;Russian Federation
2EUCTR2014-003265-19-PL
(EUCTR)
12/05/201526/02/2015Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
168Phase 2United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden
3EUCTR2014-001643-20-DE
(EUCTR)
10/02/201518/08/2014Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple SclerosisA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
168Phase 2United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden
4NCT02306811
(ClinicalTrials.gov)
February 20151/12/2014Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839Relapsing-remitting Multiple SclerosisDrug: VatelizumabGenzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth62Phase 2United States;Canada;Poland;Russian Federation
5EUCTR2014-001643-20-PL
(EUCTR)
23/01/201531/10/2014Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple SclerosisA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
168Phase 2United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden
6NCT02222948
(ClinicalTrials.gov)
September 201420/8/2014Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple SclerosisA 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 SclerosisDrug: Vatelizumab;Drug: Placebo (for Vatelizumab)Genzyme, a Sanofi CompanyNULLTerminated18 Years55 YearsBoth112Phase 2United States;Canada;Poland;Russian Federation;Sweden

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-001012-30-DE
(EUCTR)
20/01/201407/10/2013Long 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 & développementNULLNot RecruitingFemale: yes
Male: yes
80United States;Canada;Poland;Belgium;Austria;Germany;Italy
2EUCTR2013-001012-30-PL
(EUCTR)
17/10/201305/09/2013Long 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 & développementNULLNot RecruitingFemale: yes
Male: yes
80United States;Canada;Poland;Austria;Germany;Italy
3EUCTR2013-001012-30-BE
(EUCTR)
09/10/201312/08/2013Long 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 & développementNULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Canada;Poland;Belgium;Austria;Germany;Italy
4EUCTR2013-001012-30-IT
(EUCTR)
30/09/201302/07/2013Long 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 & développementNULLNot RecruitingFemale: yes
Male: yes
80United States;Canada;Poland;Austria;Germany;Italy
5EUCTR2012-002013-19-DE
(EUCTR)
25/09/201317/05/2013Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative ColitisA 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&DéveloppementNULLNot RecruitingFemale: yes
Male: yes
93France;United States;Canada;Belgium;Poland;Austria;Germany;Italy
6EUCTR2012-002013-19-PL
(EUCTR)
12/09/201314/06/2013Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative ColitisA 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&DéveloppementNULLNot RecruitingFemale: yes
Male: yes
93France;United States;Canada;Belgium;Poland;Austria;Germany;Italy
7EUCTR2013-001012-30-AT
(EUCTR)
04/09/201312/07/2013Long 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 & développementNULLNot RecruitingFemale: yes
Male: yes
80United States;Canada;Poland;Austria;Germany;Italy
8EUCTR2012-002013-19-BE
(EUCTR)
19/07/201319/02/2013Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative ColitisA 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&DéveloppementNULLNot RecruitingFemale: yes
Male: yes
93Phase 2France;United States;Canada;Poland;Belgium;Austria;Germany;Italy
9EUCTR2012-002013-19-IT
(EUCTR)
02/06/201308/04/2013Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative ColitisA 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&DéveloppementNULLNot RecruitingFemale: yes
Male: yes
93United States;France;Canada;Poland;Belgium;Austria;Germany;Italy
10EUCTR2012-002013-19-AT
(EUCTR)
16/04/201321/03/2013Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative ColitisA 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&DéveloppementNULLNot RecruitingFemale: yes
Male: yes
93France;United States;Canada;Belgium;Poland;Austria;Germany;Italy