Amg 162 (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 | 3 |
| 274 | 骨形成不全症 | 15 |
| 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 | JPRN-JapicCTI-132277 | 01/10/2013 | AMG 162 Phase III study (DESIRABLE study) | A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III) | rheumatoid arthritis | Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection Control intervention name : Placebo Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection | DAIICHISANKYO Co.,Ltd. | NULL | 20 | BOTH | 642 | Phase 3 | NULL | |||
| 2 | NCT01973569 (ClinicalTrials.gov) | October 2013 | 25/10/2013 | AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment | A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III) | Rheumatoid Arthritis | Drug: denosumab;Drug: placebo | Daiichi Sankyo, Inc. | NULL | Completed | 20 Years | N/A | All | 679 | Phase 3 | Japan |
| 3 | JPRN-JapicCTI-101263 | 01/8/2010 | DRIVE | A Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II) | Rheumatoid Arthritis | Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the intervention : AMG 162 60 mg administered subcutaneously - Every 6 months/ Every 3 months/ Every 2 months Control intervention name : Placebo Dosage And administration of the control intervention : Subcutaneously for placebo | DAIICHISANKYO Co.,Ltd. | NULL | 20 | 75 | BOTH | 320 | Phase 2 | NULL |
| 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 | EUCTR2018-000550-21-BG (EUCTR) | 01/12/2020 | 11/09/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 2 | EUCTR2018-000550-21-DE (EUCTR) | 18/09/2020 | 20/02/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - Prolia | Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 3 | EUCTR2018-000550-21-GB (EUCTR) | 07/03/2019 | 17/06/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 4 | EUCTR2018-000550-21-HU (EUCTR) | 06/07/2018 | 10/05/2018 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 5 | EUCTR2014-000184-40-BE (EUCTR) | 22/05/2015 | 23/02/2015 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Hungary;France;United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Bulgaria;Germany;United Kingdom | ||
| 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 | EUCTR2014-000184-40-GB (EUCTR) | 30/01/2015 | 26/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom | ||
| 7 | EUCTR2014-000184-40-DE (EUCTR) | 29/12/2014 | 22/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Belgium;Spain;Poland;Australia;Bulgaria;Germany;United Kingdom | ||
| 8 | EUCTR2014-000184-40-ES (EUCTR) | 19/10/2014 | 01/09/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 17.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | France;United States;Hungary;Czech Republic;Canada;Finland;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom | |||
| 9 | EUCTR2014-000184-40-HU (EUCTR) | 18/10/2014 | 29/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 19.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom | ||
| 10 | EUCTR2014-000184-40-CZ (EUCTR) | 11/09/2014 | 12/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;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 |
| 11 | EUCTR2018-000550-21-FR (EUCTR) | 27/07/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 12 | EUCTR2018-000550-21-CZ (EUCTR) | 14/02/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 13 | EUCTR2014-000184-40-Outside-EU/EEA (EUCTR) | 26/11/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 17.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: denosumab - - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc. | NULL | NA | Female: yes Male: yes | 150 | United States;Australia;Canada | ||||
| 14 | EUCTR2014-000184-40-PL (EUCTR) | 15/01/2015 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen, Inc. | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany | |||
| 15 | EUCTR2018-000550-21-PL (EUCTR) | 16/10/2018 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand | Amgen Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany |