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

  
17 trials found
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
12NCT03600805
(ClinicalTrials.gov)
November 20, 201817/7/2018Evaluation 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 ArteritisGiant Cell ArteritisDrug: Sarilumab SAR153191;Drug: Sarilumab matching placebo;Drug: Prednisone;Drug: Prednisone matching placeboSanofiRegeneron PharmaceuticalsTerminated50 YearsN/AAll83Phase 3United States;Argentina;Australia;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Austria;Finland
13EUCTR2017-002988-18-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
14EUCTR2017-002988-18-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
15EUCTR2017-002988-18-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
16EUCTR2017-002988-18-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
17EUCTR2017-002988-18-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