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 | NCT05380453 (ClinicalTrials.gov) | September 21, 2022 | 22/2/2022 | Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission | A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapy | Giant Cell Arteritis | Biological: Secukinumab 300 mg, s.c.;Drug: Placebo to match Secukinumab, s.c. | Novartis Pharmaceuticals | NULL | Recruiting | 50 Years | N/A | All | 146 | Phase 3 | Germany |
| 2 | EUCTR2020-004809-31-SE (EUCTR) | 11/01/2022 | 21/10/2021 | Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cell arteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets, USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 348 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 3 | EUCTR2020-004809-31-DK (EUCTR) | 18/11/2021 | 01/08/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 4 | EUCTR2020-004809-31-NO (EUCTR) | 16/11/2021 | 28/06/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe Product Name: Cosentyx Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 5 | EUCTR2020-004809-31-BG (EUCTR) | 08/11/2021 | 26/08/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 20mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 6 | EUCTR2020-004809-31-DE (EUCTR) | 19/10/2021 | 12/07/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 7 | EUCTR2020-004809-31-PT (EUCTR) | 13/10/2021 | 07/07/2021 | Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 348 | Phase 3 | Russian Federation;United States;Czechia;Portugal;Sweden;Netherlands;Brazil;Guatemala;Poland;France;Bulgaria;Argentina;Hungary;United Kingdom;Switzerland;Spain;New Zealand;Canada;Turkey;Belgium;Norway;Finland;Denmark;South Africa;Italy;Australia;Germany;Estonia | ||
| 8 | NCT04930094 (ClinicalTrials.gov) | October 6, 2021 | 15/6/2021 | Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA) | A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA) | Giant Cell Arteritis (GCA) | Biological: Secukinumab 300 mg;Other: Placebo;Biological: Secukinumab 150 mg | Novartis Pharmaceuticals | NULL | Recruiting | 50 Years | N/A | All | 349 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Finland;France;Germany;Guatemala;Hungary;Italy;Poland;Portugal;Russian Federation;South Africa;Spain;Switzerland;Turkey;United Kingdom |
| 9 | EUCTR2020-004809-31-FI (EUCTR) | 05/10/2021 | 16/07/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 10 | EUCTR2020-004809-31-FR (EUCTR) | 24/09/2021 | 22/06/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx Product Name: Cosentyx Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 11 | EUCTR2020-004809-31-IT (EUCTR) | 16/09/2021 | 22/10/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (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] - Musculoskeletal Diseases [C05] | Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Cosentyx Product Name: Cosentyx Product Code: [AIN457] INN or Proposed INN: SECUKINUMAB | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 12 | NCT03765788 (ClinicalTrials.gov) | January 30, 2019 | 3/12/2018 | A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis | A 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 Arteritis | Drug: Secukinumab 300 mg, s.c.;Drug: Prednisolone;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 50 Years | N/A | All | 52 | Phase 2 | Germany |
| 13 | EUCTR2018-002610-12-DE (EUCTR) | 06/12/2018 | 23/08/2018 | Study in patients with giant cell arteritis to assess efficacy of secukinumab compared to placebo | A 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) - TitAIN | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany |