41. 巨細胞性動脈炎 Giant cell arteritis Clinical trials / Disease details


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125

  
8 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2015-001758-14-IT
(EUCTR)
08/06/201620/01/2021A study to assess the efficacy and safety of Sirukumab in the treatment ofpatients with Giant Cell Arteritis, using multiple sites, and an untreatedpatient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - NA Giant Cell Arteritis (GCA)
MedDRA version: 20.0;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Trade Name: Capsule di prednisone
INN or Proposed INN: PREDNISONE
Trade Name: Prednisone Capsule
INN or Proposed INN: PREDNISONE
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone capsule
INN or Proposed INN: PREDNISONE
Other descriptive name: Prednisone
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
204Phase 3New Zealand;Sweden;United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands
2EUCTR2015-001758-14-HU
(EUCTR)
15/04/201619/01/2016A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 20.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Encorton
Product Name: Encorton
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
3EUCTR2015-001758-14-NL
(EUCTR)
04/02/201626/08/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 19.1;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
204 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
4EUCTR2015-001758-14-BG
(EUCTR)
08/01/201621/10/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 19.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
5EUCTR2015-001758-14-DE
(EUCTR)
18/12/201515/07/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 19.1;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
6EUCTR2015-001758-14-BE
(EUCTR)
14/12/201505/02/2016A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
7NCT02531633
(ClinicalTrials.gov)
October 16, 20156/7/2015Efficacy and Safety Study of Sirukumab in Patients With Giant Cell ArteritisA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell ArteritisGiant Cell ArteritisDrug: Sirukumab;Drug: Placebo to match sirukumab;Drug: Prednisone;Drug: Placebo to match prednisoneGlaxoSmithKlineNULLTerminated50 YearsN/AAll161Phase 3United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom
8EUCTR2015-001758-14-ES
(EUCTR)
30/09/201531/07/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden