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

  
15 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002528-18-DK
(EUCTR)
22/02/202230/07/2021RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency.RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency; A multicentre, randomised, double blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis receiving ongoing low-dose prednisolone treatment. - RESCUE Glucocorticoid-induced adrenal insufficiency
MedDRA version: 20.0;Level: LLT;Classification code 10001369;Term: Adrenal insufficiency NOS;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Hydrokortison orion
Product Name: hydrokortison
Product Code: H02AB09
INN or Proposed INN: hydrocortisone
Other descriptive name: HYDROCORTISONE
Copenhagen University Hospital RigshospitaletNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 4Denmark
2EUCTR2017-003978-13-RO
(EUCTR)
06/11/201907/03/2022A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
3EUCTR2017-003978-13-DK
(EUCTR)
17/09/201925/02/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Canada;United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Belgium;Romania;Denmark;Australia;Netherlands;Germany;Japan;New Zealand
4EUCTR2017-003978-13-FR
(EUCTR)
22/08/201919/04/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolone 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
5EUCTR2017-003978-13-GR
(EUCTR)
26/07/201918/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: SELECT GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
6EUCTR2017-003978-13-PT
(EUCTR)
08/07/201914/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
7EUCTR2017-003978-13-IT
(EUCTR)
02/07/201907/10/2020A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis - na 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: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
Product Code: [na]
INN or Proposed INN: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
Product Code: [na]
INN or Proposed INN: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
Product Code: [na]
INN or Proposed INN: PREDNISOLONE
Trade Name: Prednisolon 20 mg JENAPHARM
Product Name: Prednisolone
Product Code: [na]
INN or Proposed INN: PREDNISOLONE
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 10 mg JENAPHARM
Product Name: Prednisolone
Product Code: [na]
INN or Proposed INN: PREDNISOLONE
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
8EUCTR2017-003978-13-NL
(EUCTR)
26/06/201926/06/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
9EUCTR2017-003978-13-ES
(EUCTR)
22/05/201927/05/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
420 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
10EUCTR2017-003978-13-BE
(EUCTR)
15/05/201901/05/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
11EUCTR2017-003978-13-AT
(EUCTR)
15/05/201905/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
12EUCTR2017-003978-13-DE
(EUCTR)
14/05/201905/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
13EUCTR2017-003978-13-HU
(EUCTR)
08/05/201925/03/2019A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA 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]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 1 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Prednisolon 5 mg JENAPHARM
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Pr
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand
14NCT03765788
(ClinicalTrials.gov)
January 30, 20193/12/2018A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell ArteritisA Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN)Giant Cell ArteritisDrug: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted50 YearsN/AAll52Phase 2Germany
15EUCTR2011-005090-22-GB
(EUCTR)
28/02/201217/01/2012A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA Giant Cell Arteritis
MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: Lodotra
Product Name: Lodotra (delayed release prednisolone)
INN or Proposed INN: Prednisolone
Other descriptive name: 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
Southend HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom