41. 巨細胞性動脈炎 Giant cell arteritis Clinical trials / Disease details
臨床試験数 : 128 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 124
| 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 | EUCTR2017-002988-18-FI (EUCTR) | 02/10/2019 | 12/09/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;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 | ||
| 2 | EUCTR2017-002988-18-HR (EUCTR) | 15/04/2019 | 17/05/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 3 | EUCTR2017-002988-18-SI (EUCTR) | 22/03/2019 | 19/12/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 4 | EUCTR2017-002988-18-GB (EUCTR) | 04/03/2019 | 20/06/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Authorised-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): no | Sweden;Germany;Netherlands;Australia;Denmark;Croatia;Belgium;Argentina;Canada;Hungary;France;Switzerland;United Kingdom;Italy;Chile;Israel;Russian Federation;Austria;Spain;Slovenia;Estonia;United States;Portugal | ||
| 5 | EUCTR2017-002988-18-PT (EUCTR) | 25/02/2019 | 05/11/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Authorised-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): no | Portugal;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 | ||
| 6 | EUCTR2017-002988-18-AT (EUCTR) | 19/02/2019 | 28/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 7 | EUCTR2017-002988-18-FR (EUCTR) | 14/01/2019 | 09/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 8 | EUCTR2017-002988-18-DK (EUCTR) | 04/01/2019 | 29/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 9 | EUCTR2017-002988-18-NL (EUCTR) | 10/12/2018 | 01/11/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 10 | EUCTR2017-002988-18-BE (EUCTR) | 07/12/2018 | 06/03/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 11 | EUCTR2017-002988-18-DE (EUCTR) | 26/11/2018 | 26/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 12 | NCT03600805 (ClinicalTrials.gov) | November 20, 2018 | 17/7/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Sarilumab SAR153191;Drug: Sarilumab matching placebo;Drug: Prednisone;Drug: Prednisone matching placebo | Sanofi | Regeneron Pharmaceuticals | Terminated | 50 Years | N/A | All | 83 | Phase 3 | Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Argentina;Australia;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Netherlands;United States;Austria;Finland |
| 13 | EUCTR2017-002988-18-HU (EUCTR) | 19/11/2018 | 04/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 14 | EUCTR2017-002988-18-IT (EUCTR) | 08/11/2018 | 12/02/2021 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 DEVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;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 | ||
| 15 | EUCTR2017-002988-18-ES (EUCTR) | 19/10/2018 | 25/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;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 | ||
| 16 | EUCTR2017-002988-18-EE (EUCTR) | 18/10/2018 | 15/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 17 | EUCTR2017-002988-18-SE (EUCTR) | 18/10/2018 | 11/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A 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 & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United 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 |