Amg 827 (DrugBank: -)
2 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 | 14 |
96 | クローン病 | 9 |
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 |
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1 | EUCTR2009-016119-38-BG (EUCTR) | 05/10/2010 | 18/08/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;Bulgaria;Latvia;Poland | |||
2 | EUCTR2009-016119-38-LV (EUCTR) | 13/08/2010 | 28/05/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;Bulgaria;Latvia;Poland | |||
3 | EUCTR2009-016119-38-CZ (EUCTR) | 01/07/2010 | 02/07/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | Czech Republic;Poland;Bulgaria;Latvia;United Kingdom | |||
4 | EUCTR2009-016119-38-PL (EUCTR) | 23/06/2010 | 30/04/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;Bulgaria;Latvia;Poland | |||
5 | EUCTR2009-016119-38-GB (EUCTR) | 19/05/2010 | 17/03/2010 | Safety and Efficacy of AMG 827 in Subjects With RA | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | Czech Republic;United Kingdom;Bulgaria;Latvia;Poland;Australia | |||
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 | EUCTR2009-012566-32-BG (EUCTR) | 05/05/2010 | 27/04/2010 | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland | |||
7 | NCT01059448 (ClinicalTrials.gov) | May 2010 | 28/1/2010 | Safety and Efficacy of AMG 827 in Subjects With RA | A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 827 | Amgen | NULL | Terminated | N/A | N/A | Both | 211 | Phase 2 | United States;Bulgaria;Canada;Czech Republic;Latvia;Mexico;Poland;United Kingdom |
8 | EUCTR2009-012566-32-HU (EUCTR) | 31/03/2010 | 20/11/2009 | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland | |||
9 | EUCTR2009-012566-32-CZ (EUCTR) | 05/02/2010 | 01/10/2009 | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland | |||
10 | EUCTR2009-012566-32-LV (EUCTR) | 29/12/2009 | 30/10/2009 | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland | |||
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 |
11 | EUCTR2009-012566-32-PL (EUCTR) | 17/12/2009 | 09/11/2009 | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland | |||
12 | EUCTR2009-012566-32-GB (EUCTR) | 02/12/2009 | 02/08/2010 | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Hungary;Czech Republic;United Kingdom;Bulgaria;Latvia;Poland | |||
13 | NCT00950989 (ClinicalTrials.gov) | December 2009 | 30/7/2009 | AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: AMG 827 70 mg;Drug: AMG 827 140 mg;Drug: AMG 827 210 mg;Drug: Placebo;Drug: Stable weekly dose of methotrexate | Amgen | NULL | Completed | 18 Years | 70 Years | Both | 240 | Phase 2 | Bulgaria;Canada;Czech Republic;Hungary;Latvia;Mexico;Poland;United Kingdom;United States |
14 | NCT00771030 (ClinicalTrials.gov) | November 2008 | 9/10/2008 | Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 827;Other: Placebo | Amgen | NULL | Completed | 18 Years | 70 Years | Both | 40 | Phase 1;Phase 2 | Canada;Mexico;United States |
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 | EUCTR2010-020881-53-ES (EUCTR) | 25/05/2011 | 01/12/2010 | Una evaluación a largo plazo de la seguridad y la eficacia del tratamiento con AMG 827 en sujetos con enfermedad de Crohn. /A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease. | Una evaluación a largo plazo de la seguridad y la eficacia del tratamiento con AMG 827 en sujetos con enfermedad de Crohn. /A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease. | Crohn's disease / Enfermedad de Crohn MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 195 | Netherlands;Belgium;Spain | |||
2 | EUCTR2010-020881-53-NL (EUCTR) | 04/04/2011 | 17/12/2010 | A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease | A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease | Crohns Disease MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 195 | Netherlands;Belgium;Spain | |||
3 | EUCTR2010-020881-53-BE (EUCTR) | 18/01/2011 | 24/11/2010 | Safety Study in Subjects With Crohn's Disease | A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease | Crohn's Disease MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands | ||
4 | EUCTR2010-019544-39-NL (EUCTR) | 06/01/2011 | 30/08/2010 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease | Crohn’s disease MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated | Product Name: AMG 827 Product Code: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 216 | Netherlands;Belgium;France;Spain | |||
5 | NCT01199302 (ClinicalTrials.gov) | December 2010 | 9/9/2010 | Safety Study in Subjects With Crohn's Disease | A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease | Crohn's Disease | Drug: AMG 827 | Amgen | NULL | Terminated | N/A | N/A | Both | 67 | Phase 2 | United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain |
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 | EUCTR2010-019544-39-ES (EUCTR) | 25/11/2010 | 03/09/2010 | Estudio aleatorizado, a doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 827 en sujetos con enfermedad de Crohn de moderada a grave / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease | Estudio aleatorizado, a doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 827 en sujetos con enfermedad de Crohn de moderada a grave / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease | Crohn's disease / Enfermedad de Crohn MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated | Product Name: AMG 827 Product Code: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 216 | Netherlands;Belgium;France;Spain | |||
7 | EUCTR2010-019544-39-FR (EUCTR) | 04/10/2010 | 06/09/2010 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease | Crohn’s disease MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated | Product Name: AMG 827 Product Code: AMG 827 | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Netherlands;Belgium;France;Spain | |||
8 | EUCTR2010-019544-39-BE (EUCTR) | 04/10/2010 | 17/08/2010 | AMG 827 in Subjects With Moderate to Severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease | Crohn’s disease MedDRA version: 14.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands | ||
9 | NCT01150890 (ClinicalTrials.gov) | July 2010 | 24/6/2010 | AMG 827 in Subjects With Moderate to Severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: AMG 827 350 MG;Drug: AMG 827 210 MG;Drug: AMG 827 700 MG;Drug: Placebo | Amgen | NULL | Terminated | 18 Years | 65 Years | Both | 130 | Phase 2 | United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain |