Mdx-1100 (DrugBank: -)
3 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
46 | 悪性関節リウマチ | 1 |
96 | クローン病 | 3 |
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 | NCT01017367 (ClinicalTrials.gov) | February 2008 | 16/11/2009 | Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA) | Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: MDX-1100;Drug: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 70 | Phase 2 | Romania;Ukraine |
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 | EUCTR2011-002981-19-PL (EUCTR) | 21/03/2012 | 12/01/2012 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease.Revised Protocol 043 incorporating Protocol Amendment 05Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.1;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2a | United States;France;Hungary;Belgium;Poland;South Africa | ||
2 | EUCTR2011-002981-19-HU (EUCTR) | 06/03/2012 | 27/12/2011 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2a | France;United States;Hungary;Belgium;Poland;South Africa | ||
3 | EUCTR2011-002981-19-BE (EUCTR) | 14/02/2012 | 14/12/2011 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2a | France;United States;Hungary;Poland;Belgium;South Africa |
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 | EUCTR2010-022506-41-PL (EUCTR) | 24/10/2011 | 05/09/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 | Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2b | United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany | ||
2 | EUCTR2010-022506-41-BE (EUCTR) | 23/08/2011 | 17/06/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05 | Colitis, Ulcerative MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2 | United States;Austria;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Australia;South Africa;Netherlands;Germany | ||
3 | EUCTR2010-022506-41-DE (EUCTR) | 18/07/2011 | 28/02/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2b | United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Germany;Netherlands | ||
4 | EUCTR2010-022506-41-HU (EUCTR) | 31/05/2011 | 13/04/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05 | Colitis, Ulcerative MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2b | United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany | ||
5 | EUCTR2010-022506-41-AT (EUCTR) | 05/05/2011 | 01/03/2011 | Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 386 | Phase 2b | United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Netherlands;Germany | ||
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 | EUCTR2007-002544-25-CZ (EUCTR) | 21/10/2008 | 07/01/2008 | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: MDX-1100 Product Code: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 2 | Hungary;Czech Republic;Latvia | ||
7 | EUCTR2007-002544-25-LV (EUCTR) | 29/05/2008 | 18/02/2008 | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: MDX-1100 Product Code: MDX-1100 | Bristol-Myers Squibb Company | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 2 | Hungary;Czech Republic;Latvia | ||
8 | EUCTR2007-002544-25-HU (EUCTR) | 23/05/2008 | 07/01/2008 | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: MDX-1100 Product Code: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 2 | Hungary;Czech Republic;Latvia | ||
9 | NCT00656890 (ClinicalTrials.gov) | April 2008 | 4/4/2008 | A Study of MDX-1100 in Subjects With Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Biological: sterile saline for injection;Biological: MDX-1100 | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 110 | Phase 2 | United States;Canada;Czech Republic;Hungary;Latvia;Romania;Russian Federation;Ukraine |
10 | NCT00295282 (ClinicalTrials.gov) | January 2006 | 21/2/2006 | A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis | A Phase I, Multicenter, Dose-escalation Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: MDX-1100 (anti-CXCL10 human monoclonal antibody) | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 24 | Phase 1 | United States |