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
| 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 | EUCTR2017-003978-13-RO (EUCTR) | 06/11/2019 | 07/03/2022 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 2 | EUCTR2017-003978-13-DK (EUCTR) | 17/09/2019 | 25/02/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Canada;United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Belgium;Romania;Denmark;Australia;Netherlands;Germany;Japan;New Zealand | ||
| 3 | EUCTR2017-003978-13-FR (EUCTR) | 22/08/2019 | 19/04/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 4 | EUCTR2017-003978-13-GR (EUCTR) | 26/07/2019 | 18/03/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 5 | EUCTR2017-003978-13-PT (EUCTR) | 08/07/2019 | 14/03/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 6 | EUCTR2017-003978-13-IT (EUCTR) | 02/07/2019 | 07/10/2020 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 7 | EUCTR2017-003978-13-NL (EUCTR) | 26/06/2019 | 26/06/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 8 | EUCTR2017-003978-13-ES (EUCTR) | 22/05/2019 | 27/05/2019 | A 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. KG | NULL | Authorised-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): no | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 9 | EUCTR2017-003978-13-AT (EUCTR) | 15/05/2019 | 05/03/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 10 | EUCTR2017-003978-13-BE (EUCTR) | 15/05/2019 | 01/05/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 11 | EUCTR2017-003978-13-DE (EUCTR) | 14/05/2019 | 05/03/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 12 | EUCTR2017-003978-13-HU (EUCTR) | 08/05/2019 | 25/03/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;Greece;Spain;Austria;Russian Federation;Italy;France;Hungary;Canada;Belgium;Romania;Australia;Denmark;Netherlands;Germany;Japan;New Zealand | ||
| 13 | NCT03725202 (ClinicalTrials.gov) | January 24, 2019 | 27/10/2018 | A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants 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 (GCA) | Drug: Upadacitinib;Drug: Corticosteroid (CS);Other: Placebo | AbbVie | NULL | Recruiting | 50 Years | N/A | All | 420 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Netherlands;New Zealand;Norway;Portugal;Romania;Russian Federation;Spain;Sweden;Switzerland;United Kingdom |