Kevzara ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
41巨細胞性動脈炎16
46悪性関節リウマチ12

41. 巨細胞性動脈炎


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002988-18-FI
(EUCTR)
02/10/201912/09/2019Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3Portugal;Serbia;United States;Estonia;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Slovenia;Finland;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Croatia;Germany;Norway;Sweden
2EUCTR2017-002988-18-HR
(EUCTR)
15/04/201917/05/2019Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
3EUCTR2017-002988-18-SI
(EUCTR)
22/03/201919/12/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
4EUCTR2017-002988-18-GB
(EUCTR)
04/03/201920/06/2019Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
508 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Estonia;Slovenia;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
5EUCTR2017-002988-18-PT
(EUCTR)
25/02/201905/11/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
6EUCTR2017-002988-18-AT
(EUCTR)
19/02/201928/09/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
7EUCTR2017-002988-18-FR
(EUCTR)
14/01/201909/10/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
8EUCTR2017-002988-18-DK
(EUCTR)
04/01/201929/09/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
9EUCTR2017-002988-18-NL
(EUCTR)
10/12/201801/11/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
10EUCTR2017-002988-18-BE
(EUCTR)
07/12/201806/03/2019Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
11EUCTR2017-002988-18-DE
(EUCTR)
26/11/201826/09/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
12EUCTR2017-002988-18-HU
(EUCTR)
19/11/201804/10/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
13EUCTR2017-002988-18-IT
(EUCTR)
08/11/201812/02/2021Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate theefficacy and safety of sarilumab in patients with giant cell arteritis - n.a. Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
Product Name: NA
Product Code: [NA]
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
Product Name: na
Product Code: [na]
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
Product Name: NA
Product Code: [NA]
INN or Proposed INN: PREDNISONE
Trade Name: Cortancyl ® 1 mg
Product Name: na
Product Code: [na]
INN or Proposed INN: PREDNISONE
Trade Name: Cortancyl ® 20 mg
Product Name: NA
Product Code: [NA]
INN or Proposed INN: PREDNISONE
Trade Name: Cortancyl ® 5 mg
Product Name: NA
Product Code: [NA]
INN or Proposed INN: PREDNISONE
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
508Phase 3Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
14EUCTR2017-002988-18-ES
(EUCTR)
19/10/201825/10/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
15EUCTR2017-002988-18-SE
(EUCTR)
18/10/201811/10/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
16EUCTR2017-002988-18-EE
(EUCTR)
18/10/201815/10/2018Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAA randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis Giant Cell Arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Kevzara ®
INN or Proposed INN: SARILUMAB
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 1 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Cortancyl ® 5 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
508Phase 3United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005998-27-DK
(EUCTR)
12/03/202125/01/2021Interleukin-6 inhibitors and drug-drug interactions in patients with Rheumatoid Arthritis.Interleukin-6 inhibitors and drug-drug interactions in patients with Rheumatoid Arthritis. Rheumatoid arthritis
MedDRA version: 23.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Product Name: Kevzara
INN or Proposed INN: SARILUMAB
Other descriptive name: Sarilumab
Product Name: Kevzara
INN or Proposed INN: SARILUMAB
Other descriptive name: Sarilumab
University of Southern DenmarkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 1;Phase 2Denmark
2EUCTR2019-004078-24-ES
(EUCTR)
07/05/202021/02/2020Effect of Sarilumab on atherosclerotic disease in Rheumatoid ArthritisEffect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis - SARIPET RHEUMATOID ARTHRITIS
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: KEVZARA
INN or Proposed INN: SARILUMAB
IDIVALNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Spain
3NCT04350216
(ClinicalTrials.gov)
April 30, 20208/4/2020Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid ArthritisRheumatoid Arthritis;AtherosclerosisDrug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]Instituto de Investigación Marqués de ValdecillaNULLNot yet recruiting18 Years100 YearsAll20Phase 4NULL
4EUCTR2019-000868-18-DE
(EUCTR)
13/03/202008/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
5EUCTR2019-000868-18-IT
(EUCTR)
18/12/201917/06/2021Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 20.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: N/A
Product Name: Otilimab
Product Code: [GSK3196165]
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
Product Code: [N/A]
INN or Proposed INN: Sarilumab
Trade Name: NA
Product Name: Otilimab
Product Code: [GSK3196165]
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: NA
Product Name: Otilimab
Product Code: [GSK3196165]
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of
6EUCTR2019-000868-18-GB
(EUCTR)
02/12/201911/06/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Kevzara
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colo
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
7EUCTR2019-000868-18-PL
(EUCTR)
15/11/201911/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Antihuman granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;China;Japan;Korea, Republic of
8EUCTR2019-000868-18-ES
(EUCTR)
14/11/201926/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of
9EUCTR2019-000868-18-HU
(EUCTR)
24/10/201928/10/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
10EUCTR2019-000868-18-LT
(EUCTR)
11/10/201919/07/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Czechia;Spain;Lithuania;Italy;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
11EUCTR2019-000868-18-CZ
(EUCTR)
20/09/201920/08/2019Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3 Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Argentina;Hungary;United States;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Belgium;China;Korea, Republic of;Poland;Italy;South Africa;Lithuania;Germany
12NCT03378219
(ClinicalTrials.gov)
May 18, 201815/12/2017An Observational Study on Sarilumab-exposed PregnanciesKevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance StudyRheumatoid Arthritis -Exposure During PregnancyDrug: Sarilumab SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsActive, not recruitingN/AN/AFemale113United States;Canada