AMG 162 ( DrugBank: - )

2 diseases

ID	Disease name (Link within this page)	Number of trials
46	Malignant rheumatoid arthritis	3
274	Osteogenesis Imperfecta	21

46. Malignant rheumatoid arthritis

Clinical trials : 4,325 / Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224

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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 ...	rheumatoid arthritis	Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the inter ...	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 Dise ...	A Confirmatory Study of AMG 162(Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment ...	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 (M ...	Rheumatoid Arthritis	Intervention name : AMG 162 INN of the intervention : Denosumab Dosage And administration of the inter ...	DAIICHISANKYO Co.,Ltd.	NULL		20	75	BOTH	320	Phase 2	NULL

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274. Osteogenesis Imperfecta

Clinical trials : 87 / Drugs : 103 - (DrugBank : 20) / Drug target genes : 14 - Drug target pathways : 76

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	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 Childr ...	Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ...	Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	Amgen Inc	NULL	Not Recruiting	Female: yes Male: yes	150	Phase 3	United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Austral ...
2	EUCTR2014-000184-40-PL (EUCTR)	13/10/2020	15/01/2015	Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ...	Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Den ...	Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	Amgen, Inc.	NULL	Not Recruiting	Female: yes Male: yes	150	Phase 3	United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium ...
3	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 Childr ...	Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ...	Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	Amgen Inc	NULL	Not Recruiting	Female: yes Male: yes	150	Phase 3	United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland ...
4	EUCTR2018-000550-21-CZ (EUCTR)	31/03/2020	14/02/2020	Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Childr ...	Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ...	Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	150	Phase 3	United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland ...
5	EUCTR2018-000550-21-ES (EUCTR)	01/10/2019	05/07/2019	Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Childr ...	Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ...	Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	Amgen Inc	NULL	Not Recruiting	Female: yes Male: yes	150	Phase 3	United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Austral ...
6	EUCTR2018-000550-21-IT (EUCTR)	21/06/2019	15/06/2021	Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumab in Childre ...	Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ...	Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ...	Trade Name: XGEVA Product Name: Denosumab Product Code: [AMG 162] INN or Proposed INN: Denosumab Other d ...	AMGEN INC.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	150	Phase 3	United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgiu ...
7	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 Childr ...	Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ...	Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	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;Austral ...
8	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 Childr ...	Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ...	Osteogenesis Imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	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;Austral ...
9	EUCTR2014-000184-40-BE (EUCTR)	22/05/2015	23/02/2015	Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ...	Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Den ...	Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	Amgen Inc.	NULL	Not Recruiting	Female: yes Male: yes	150	Phase 3	United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland ...
10	EUCTR2014-000184-40-GB (EUCTR)	30/01/2015	26/08/2014	Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ...	Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Den ...	Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ...	Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ...	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;U ...

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